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U.S. Department of Health and Human Services

Enforcement Report - Week of August 22, 2012

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Product Type Product Description Code Info Classification Reason for Recall Recalling Firm
Devices Alaris Pump Module model 8100. Subsequent product code: FPA The Pump module is intended for facilities that utilize infusion for the delivery of fluids, medications, blood, and blood products using continuous or intermittent delivery through clinically acceptable routes of administration; such as, intravenous (IV), intra-arterial (IA),subcutaneous, epidural, enteral, or irrigation of fluid spaces. The Pump module is indicated for use on adults, pediatrics, and neonates. All serial numbers associated with the Alaris Pump Module Model 8100: 8100 DEMO PUMP MODULE; 8100 Global Pump Module; 8100 IOC Pump Module V8.5.29.0; 8100 LVP Training Unit; 8100 Pump Module V8.5.29.0; 8100 Pump Module V8.5.29.0 (V9); Medley Patient Care System LVP; Model 8100 Trade-In Material; RCND 8100 Pump Module V8.5.29.0 Class I The recall was initiated because Carefusion identified a potential risk associated with the Alaris Pump module model 8100. Carefusion has received reports of customers experiencing motor stalls during infusion with Alaris Pump Module (model 8100) manufactured between August 2010 and July 2011. CareFusion 303, Inc.
Devices GE Healthcare Advantage Workstations, Advantage Worksation version 4.2 and 4.3 with Volume Viewer 2 (version 6.4-6.8) provided with Advance Vessel Analysis (AVA) and Advantage Workstation 4.4 with Volume Viewer 2 (version 6.8 or before) or Volume Viewer 3 (version 7.2 -7.3) provided with Advanced Vessel Analysis (AVA), Model 2378698-2 Product Usage: Advantage Workstation version 4.2: The Advantage Workstation 4.2 is a review station, which allows easy selection, review, processing, filming and medial interchange of multi-modality images from a variety of diagnostic imaging systems. When interpreted by a trained physician, filmed images may be used as an element for diagnosis. Advantage Workstation version 4.3/4.4 : The Advantage Workstation 4.3 is a review station, which allows easy selection, review, processing, filming and medial interchange of multi-modality DIACOM images from a variety of diagnostic imaging systems. When interpreted by a trained physician, filmed images of the AW monitor may be used as a basis for diagnosis, except in the case of mammography. 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082421100270AW 00000LEE5B234C RU2650AW01 000D1L02387E4E 0828490001 000D1L0238A8CC 082421080068AW 000D1L0274ACB0 0828210061AW01 000D1L610083F8 M27534 000D1LEE1BC41D NP384112 Class II GE Healthcare is informing you of incorrect measurements when using the Aorta analysis protocol or customized protocols. Until a new software version is installed they are asking you not to use the aorta analysis protocol or the customized protocols for an aneurysm. A second issue was also discovered internally. When loading PET data into the Volume Viewer, if slices are missing in a PET series (i.e., from a networking error, or operator error), the Volume Viewer application will interpolate from neighboring slices to fill these gaps when loading the series without any warning. Thus, if a small lesion is located in any of the missing slices, it may not appear on the interpolated slices. GE Healthcare, LLC
Veterinary The bag is labeled DuMOR Poultry Grower/Finisher Net Wt 50 lb Manufactured Exclusively For Tractor Supply Company 200 Powell Place, Brentwood, TN 37027 The feed tag is labeled DuMOR Poultry Layer 16% Crumble Manufactured for Tractor Supply Company, 200 Powell Place, Brentwood, TN 37027 Net Wt 50 lb 2MAR15OKC1 Class I The product was incorrectly packaged into the wrong bag. Land O Lakes Purina LLC
Devices Neptune Waste Management System Instructions For Use , Neptune Rover(120V); Neptune Rover (230 V). Intended for use in the surgical environment or physician's office to collect and dispose of surgical fluid waste. IFU Part numbers 0700-001-700 for Neptune part numbers : 0700-001-000 and 0700-003-000, all lot numbers Class I Stryker received one report of a fatality from a customer in which the Neptune Rover was connected to a passive chest drainage tube post-operatively. Connecting the Neptune Rover (a high vacuum/high flow device), instead of using a post-operative low suction application, may have resulted in hemorrhage, which led to death. Stryker Instruments Div. of Stryker Corporation
Devices Neptune 2 Rover Ultra (120 V and 230 V) Waste Management System Instructions For Use Intended for use in the surgical environment or physician's office to collect and dispose of surgical fluid waste. IFU Part numbers 0702-002-700 for part numbers 0700-001-000 and 0700-002- 000, all lot numbers Class I Stryker received one report of a fatality from a customer in which the Neptune Rover was connected to a passive chest drainage tube post-operatively. Connecting the Neptune Rover (a high vacuum/high flow device), instead of using a post-operative low suction application, may have resulted in hemorrhage, which led to death. Stryker Instruments Div. of Stryker Corporation
Devices Neptune Bronze Rover Waste Management System Instructions For Use. Intended for use in the surgical environment or physician's office to collect and dispose of surgical fluid waste. IFU Part numbers 0700-007-720 for part numbers : 0700-007-000, all lot numbers Class I Stryker received one report of a fatality from a customer in which the Neptune Rover was connected to a passive chest drainage tube post-operatively. Connecting the Neptune Rover (a high vacuum/high flow device), instead of using a post-operative low suction application, may have resulted in hemorrhage, which led to death. Stryker Instruments Div. of Stryker Corporation
Devices Neptune International Gold Rover Waste Management System Instructions For Use for 230V system. Intended for use in the surgical environment or physician's office to collect and dispose of surgical fluid waste. IFU for part 0700-002-000, all lot numbers Class I Stryker received one report of a fatality from a customer in which the Neptune Rover was connected to a passive chest drainage tube post-operatively. Connecting the Neptune Rover (a high vacuum/high flow device), instead of using a post-operative low suction application, may have resulted in hemorrhage, which led to death. Stryker Instruments Div. of Stryker Corporation
Food FunFresh Foods World Berry Organic Cacao Nibs 6 oz, packaged in blue, brown, red, white, black and green packaging with red, black, yellow, white, and green print writing. The packaging is resealable. Lot number 161104 with use by date 4/2014 Class III FunFresh Foods World Berry Cacao Nibs 6 oz snack food contaminated with E. coli. FunFresh Foods Inc
Devices BeautyAngel Health Fitness Natural Collagen Stimulation Anti Aging For human use. All Beauty Angel Models and Serial Numbers Part Numbers 80000904301 and 8001110201. Class II The Beauty Angel was marketed without a 510k. JK Products & Services, Inc
Biologics Red Blood Cells Leukocytes Reduced W120612088897 Class II Blood products, possibly contaminated with air, were distributed. Michigan Blood
Biologics Red Blood Cells Leukocytes Reduced W120612004634 Class III Blood product, collected from a donor in which donor suitability was not adequately determined, was distributed. Michigan Blood
Biologics Source Plasma 2160059500; 2160066675; 2160070894; 2160078339; Class III Source Plasma, collected from a donor, whose suitability to donate was not adequately determined, was distributed. Plasmacare Inc
Biologics Source Plasma 2160078618 Class III Blood Product, collected from a donor, whose suitability to donate was not adequately determined, was distributed. Plasmacare Inc
Biologics Source Plasma 2160074117; 2160078385; 2160079350; 2160059861; 2160061927; 2160063919; Class III Blood Products, collected from a donor, whose suitability to donate was not adequately determined, were distributed. Plasmacare Inc
Biologics Source Plasma 2160063846; 2160067368; 2160071022; Class III Blood Products, collected from a donor, whose suitability to donate was not adequately determined, were distributed Plasmacare Inc
Biologics Source Plasma 2160063923; 2160065015 Class III Blood Products, collected from a donor whose suitability to donate was not adequately determined, were distributed. Plasmacare Inc
Biologics Source Plasma 2160063950; 2160064172; 2160065690; 2160065887; 2160067361; 2160068449 Class III Blood Products, collected from a donor whose suitability to donate was not adequately determined, were distributed. Plasmacare Inc
Biologics Red Blood Cells Leukocytes Reduced Irradiated W333612052335 Class II Blood product, mislabeled as to antigen phenotype, was distributed. Mississippi Valley Reg Bld Ctr
Biologics Red Blood Cells (Apheresis) Leukocytes Reduced W043212037217-A; W043212037217-B Class II Blood products, collected from a donor who traveled to a malarial endemic area, were distributed. Blood Assurance Inc
Biologics Red Blood Cells Leukocytes Reduced W041912010004J Class II Blood product, which did not meet acceptable product specifications, was distributed. Blood Systems, Inc.
Biologics Source Plasma 2160066726; 2160067353 Class III Blood Products, collected from a donor whose suitability to donate was not adequately determined, were distributed. Plasmacare Inc
Biologics Source Plasma 2160066911; 2160071456 Class III Blood Products, collected from a donor whose suitability to donate was not adequately determined, were distributed. Plasmacare Inc
Biologics Source Plasma 2160082796; 2160077160; 2160079643; 2160081153 Class III Blood Products, collected from a donor whose suitability to donate was not adequately determined, were distributed Plasmacare Inc
Biologics Source Plasma 2160081849 Class III Blood Product, collected from a donor, whose suitability to donate was not adequately determined, was distributed. Plasmacare Inc
Biologics Source Plasma 2160073463 Class III Blood Product, collected from a donor, whose suitability to donate was not adequately determined, was distributed. Plasmacare Inc
Biologics Source Plasma 2160068895 Class III Blood Product, collected from a donor, whose suitability to donate was not adequately determined, was distributed. Plasmacare Inc
Biologics Source Plasma 2160065609; 2160069670; 2160058325; 2160063971; 2160080331; 2160081165; 2160064206 Class III Blood Products, collected from a donor whose suitability to donate was not adequately determined, were distributed Plasmacare Inc
Biologics Source Plasma 2160070898 Class III Blood Product, collected from a donor, whose suitability to donate was not adequately determined, was distributed. Plasmacare Inc
Biologics Source Plasma 2160065033; 2160073124; Class III Blood Products, collected from a donor, whose suitability to donate was not adequately determined, were distributed. Plasmacare Inc
Biologics Source Plasma 2160057641; Class III Blood Product, collected from a donor, whose suitability to donate was not adequately determined, was distributed. Plasmacare Inc
Biologics Source Plasma 2160078367; 2160073485; 2160069938; 2160067984; 2160081122; 2160082792; 2160069055; Class III Blood Products, collected from a donor, whose suitability to donate was not adequately determined, were distributed. Plasmacare Inc
Biologics Source Plasma 2160072827; Class III Blood Product, collected from a donor, whose suitability to donate was not adequately determined, was distributed. Plasmacare Inc
Biologics Source Plasma 2160068777; 2160070279; 2160079153; Class III Blood Products, collected from a donor, whose suitability to donate was not adequately determined, were distributed. Plasmacare Inc
Biologics Source Plasma 2160059954; 2160073116; Class III Blood Products, collected from a donor, whose suitability to donate was not adequately determined, were distributed. Plasmacare Inc
Biologics Source Plasma 2160079113; 2160079445; Class III Blood Products, collected from a donor, whose suitability to donate was not adequately determined, were distributed. Plasmacare Inc
Biologics Source Plasma 2160057765; Class III Blood Product, collected from a donor, whose suitability to donate was not adequately determined, was distributed. Plasmacare Inc
Biologics Source Plasma 2160060981; Class III Blood Product, collected from a donor, whose suitability to donate was not adequately determined, was distributed. Plasmacare Inc
Biologics Source Plasma 2160076135; 2160076922; 2160077844; Class III Blood Products, collected from a donor, whose suitability to donate was not adequately determined, were distributed. Plasmacare Inc
Biologics Source Plasma 2160081453; Class III Blood Product, collected from a donor, whose suitability to donate was not adequately determined, was distributed. Plasmacare Inc
Biologics Source Plasma 2160064006; 2160075573; 2160076829; 2160061898; Class III Blood Products, collected from a donor, whose suitability to donate was not adequately determined, were distributed. Plasmacare Inc
Biologics Source Plasma 2160082410; Class III Blood Product, collected from a donor, whose suitability to donate was not adequately determined, was distributed. Plasmacare Inc
Biologics Source Plasma 2160065902; 2160079806; 2160064120; 2160065020; Class III Blood Products, collected from a donor, whose suitability to donate was not adequately determined, were distributed. Plasmacare Inc
Biologics Source Plasma 2160067926; 2160072756; 2160074622; 2160078027; Class III Blood Products, collected from a donor, whose suitability to donate was not adequately determined, were distributed. Plasmacare Inc
Biologics Source Plasma 2160082675; Class III Blood Product, collected from a donor, whose suitability to donate was not adequately determined, was distributed. Plasmacare Inc
Biologics Source Plasma 2160071331; 2160078237; Class III Blood Products, collected from a donor, whose suitability to donate was not adequately determined, were distributed. Plasmacare Inc
Biologics Source Plasma 2160066701; Class III Blood Product, collected from a donor, whose suitability to donate was not adequately determined, was distributed. Plasmacare Inc
Biologics Source Plasma 2160081688; Class III Blood Product, collected from a donor, whose suitability to donate was not adequately determined, was distributed. Plasmacare Inc
Biologics Source Plasma 2160066695; 2160076973; Class III Blood Products, collected from a donor, whose suitability to donate was not adequately determined, were distributed. Plasmacare Inc
Biologics Source Plasma 2160071334; Class III Blood Product, collected from a donor, whose suitability to donate was not adequately determined, was distributed. Plasmacare Inc
Biologics Source Plasma 2160058195; 2160059857; 2160061510; 2160062905; 2160081661; Class III Blood Products, collected from a donor, whose suitability to donate was not adequately determined, were distributed. Plasmacare Inc
Biologics Source Plasma 2160077103; 2160078602; 2160081098; 2160082376; 2160084416; Class III Blood Products, collected from a donor, whose suitability to donate was not adequately determined, were distributed. Plasmacare Inc
Biologics Source Plasma 2160065626; 2160069862; 2160065099; 2160071534; 2160078289; 2160080239; Class III Blood Products, collected from a donor, whose suitability to donate was not adequately determined, were distributed. Plasmacare Inc
Biologics Source Plasma 2160063553; Class III Blood Product, collected from a donor, whose suitability to donate was not adequately determined, was distributed. Plasmacare Inc
Devices Edwards Lifesciences Swan-Ganz Thermodilution VIP Catheters Model 131F7J. For use in patients who require hemodynamic monitoring. 59243259, 59263146 Class II The device is being recalled because the firm received multiple complaints related to passage of a J-tip guidewire when inserted through the distal lumen hub of the catheter. Edwards Lifesciences, LLC
Devices Edwards Lifesciences Swan-Ganz Thermodilution VIP Catheters Model 131F7P. For use in patients who require hemodynamic monitoring. 59194311, 59194312, 59194313, 59197002, 59197003, 59197893, 59197894, 59197895, 59197896, 59203369, 59203370, 59203371, 59203372, 59203373, 59219841, 59219842, 59219844, 59219845, 59224417, 59247409, 59247410, 59247411, 59247413 Class II The device is being recalled because the firm received multiple complaints related to passage of a J-tip guidewire when inserted through the distal lumen hub of the catheter. Edwards Lifesciences, LLC
Devices Edwards Lifesciences Swan-Ganz Thermodilution VIP Catheters Model 131HF7J. For use in patients who require hemodynamic monitoring. 59174383, 59174384, 59216111, 59219855, 59233891, 59247471, 59252542 Class II The device is being recalled because the firm received multiple complaints related to passage of a J-tip guidewire when inserted through the distal lumen hub of the catheter. Edwards Lifesciences, LLC
Devices Edwards Lifesciences Swan-Ganz Thermodilution VIP Catheters Model 131HF7P. For use in patients who require hemodynamic monitoring. 59169527, 59169528, 59174318, 59174320, 59194314, 59194315, 59194316, 59194317, 59197004, 59197005, 59197006, 59197007, 59197008, 59197009, 59197010, 59197897, 59197898, 59197899, 59197900, 59197901, 59197902, 59197903, 59203374. 59203375, 59203377, 59203378, 59203379, 59203380, 59203381, 59207074, 59207075, 59207076, 59207077, 59216092, 59216093, 59216094, 59216096, 59216097, 59216098, 59216099, 59219846, 59230687, 59230688, 59230689, 59230690, 59230691, 59230692, 59233882, 59238962, 59238963, 59238964, 59238965, 59243250, 59243249, 59247419, 59247421, 59247420, 59247422, 59247423, 59247424, 59247425, 59247426, 59247427, 59247428, 59247429 Class II The device is being recalled because the firm received multiple complaints related to passage of a J-tip guidewire when inserted through the distal lumen hub of the catheter. Edwards Lifesciences, LLC
Devices Edwards Lifesciences Swan-Ganz Thermodilution VIP Catheters Model 131HVF7P. For use in patients who require hemodynamic monitoring. 59197000, 59197001, 59216091, 59218827, 59238961 Class II The device is being recalled because the firm received multiple complaints related to passage of a J-tip guidewire when inserted through the distal lumen hub of the catheter. Edwards Lifesciences, LLC
Devices Edwards Lifesciences Swan-Ganz Thermodilution VIP Catheters Model 141F7. For use in patients who require hemodynamic monitoring. 59194300, 59203362, 59216087, 59233785, 59243242 Class II The device is being recalled because the firm received multiple complaints related to passage of a J-tip guidewire when inserted through the distal lumen hub of the catheter. Edwards Lifesciences, LLC
Devices Edwards Lifesciences Swan-Ganz Thermodilution VIP Catheters Model 141HF7J. For use in patients who require hemodynamic monitoring. 59194334, 59224788, 59239507, 59247472 Class II The device is being recalled because the firm received multiple complaints related to passage of a J-tip guidewire when inserted through the distal lumen hub of the catheter. Edwards Lifesciences, LLC
Devices Edwards Lifesciences Swan-Ganz Thermodilution VIP Catheters Model 141HF7P. For use in patients who require hemodynamic monitoring. 59174297, 59194298, 59194299, 59197887, 59203360, 59203361, 59207070, 59219837, 59247401, 59247402 Class II The device is being recalled because the firm received multiple complaints related to passage of a J-tip guidewire when inserted through the distal lumen hub of the catheter. Edwards Lifesciences, LLC
Devices Edwards Lifesciences Swan-Ganz Thermodilution VIP Catheters Model 151F7. For use in patients who require hemodynamic monitoring. 59174304, 59174305, 59174306, 59196997, 59211405, 59211406, 59211407, 59211408, 59216088, 59233788, 59233789, 59253934, 59252521, 59252522, 59252523, 59252524 Class II The device is being recalled because the firm received multiple complaints related to passage of a J-tip guidewire when inserted through the distal lumen hub of the catheter. Edwards Lifesciences, LLC
Devices Edwards Lifesciences Swan-Ganz Thermodilution VIP Catheters Model 151HF7. For use in patients who require hemodynamic monitoring. 59163071, 59174300, 59178366, 59233787 Class II The device is being recalled because the firm received multiple complaints related to passage of a J-tip guidewire when inserted through the distal lumen hub of the catheter. Edwards Lifesciences, LLC
Devices Edwards Lifesciences Swan-Ganz Thermodilution VIP Catheters Model TS057HF7. For use in patients who require hemodynamic monitoring. 59267057 Class II The device is being recalled because the firm received multiple complaints related to passage of a J-tip guidewire when inserted through the distal lumen hub of the catheter. Edwards Lifesciences, LLC
Devices Carestream DRX-1 System Battery --- Made in U.S.A. for Carestream Health, Inc., Carestream Health, Inc., 150 Verona St, Rochester, NY 14608. --- The battery may be sold with the DRX-1 imaging device or as a stand-alone accessory. All DRX-1 batteries manufactured before June 2012. Class II Carestream DRX-1 System batteries manufactured before June 2012 due to two occurrences of lithium-ion battery overheating, which may cause burns. Carestream Health, Inc.
Devices Sunquest Laboratory SMART & Sunquest Laboratory SMART Select Version 6.3.0 and Later Class III In Online Entry (OEx) there are two scenarios where a Test result from one container may file to a Test on another container. In order for this to occur: 1) Site parameter SIT 1,2,1,26 (3,217) [Restrict resulting of tests to owner container (/N)]=Y. 2) The Tests are ordered on the same accession number and 3) The Test codes are defined to have the same upload code as either replicate or subtests. Sunquest Information Systems, Inc.
Drugs ACETAZOLAMIDE, LYOPHILIZED 500MG INJECTABLE10 VIAL, 4 VIAL, 5 VIAL, 6 VIAL, 8 VIAL (5 DIFFERENT PRODUCTS) Rx #'s: 0390522, 0390522, 0353081, 0390522, 0390522, 0398989 Class II Lack of Assurance of Sterility: Franck's Lab Inc. initiated a recall of all Sterile Human Drugs distributed between 11/21/2011 and 05/21/2012 because FDA environmental sampling revealed the presence of microorganisms and fungal growth in the clean room where sterile products were prepared. Franck's Lab Inc., d.b.a. Franck's Compounding Lab
Drugs ACETIC ACID, IRRIGATION 3% SOLUTION 500 ML (1 PRODUCT) Rx #: T0389114 Class II Lack of Assurance of Sterility: Franck's Lab Inc. initiated a recall of all Sterile Human Drugs distributed between 11/21/2011 and 05/21/2012 because FDA environmental sampling revealed the presence of microorganisms and fungal growth in the clean room where sterile products were prepared. Franck's Lab Inc., d.b.a. Franck's Compounding Lab
Drugs ACETYLCYSTEINE, OPHTHALMIC IN ARTIFICIAL TEARS 10% SOLUTION 10 ML, 2 ML, 5 ML, 6 ML; ACETYLCYSTEINE, OPHTHALMIC IN ARTIFICIAL TEARS 2.5% SOLUTION 20 ML; ACETYLCYSTEINE, OPHTHALMIC IN ARTIFICIAL TEARS 5% SOLUTION 3 ML (6 DIFFERENT PRODUCTS) Rx #'s: 0398691, 0401304, 0403533, 0385192, 0407592, 0394079, 0388572, 0391271, 0400529 Class II Lack of Assurance of Sterility: Franck's Lab Inc. initiated a recall of all Sterile Human Drugs distributed between 11/21/2011 and 05/21/2012 because FDA environmental sampling revealed the presence of microorganisms and fungal growth in the clean room where sterile products were prepared. Franck's Lab Inc., d.b.a. Franck's Compounding Lab
Drugs ACYCLOVIR OPHTHALMIC 3% OINTMENT 5 GM; ACYCLOVIR OPHTHALMIC 3% SOLUTION 5 ML (2 DIFFERENT PRODUCTS) Rx #'s: 0384117, 0407161 Class II Lack of Assurance of Sterility: Franck's Lab Inc. initiated a recall of all Sterile Human Drugs distributed between 11/21/2011 and 05/21/2012 because FDA environmental sampling revealed the presence of microorganisms and fungal growth in the clean room where sterile products were prepared. Franck's Lab Inc., d.b.a. Franck's Compounding Lab
Drugs AFLIBERCEPT, SDPF - (0.05ML SYRINGE, 31G, 5/16") 40MG/ML INJECTABLE 0.35 ML, 0.95 ML, 1.25 ML (3 DIFFERENT PRODUCTS) Rx #'s: 0391287, 0398843, 0398843 Class II Lack of Assurance of Sterility: Franck's Lab Inc. initiated a recall of all Sterile Human Drugs distributed between 11/21/2011 and 05/21/2012 because FDA environmental sampling revealed the presence of microorganisms and fungal growth in the clean room where sterile products were prepared. Franck's Lab Inc., d.b.a. Franck's Compounding Lab
Drugs ALPROSTADIL 10MCG/ML INJECTABLE 10 ML, 20 ML, 3 ML, 30 ML, 5 ML, 6 ML; ALPROSTADIL 15MCG/ML INJECTABLE 5 ML; ALPROSTADIL 20MCG/ML INJECTABLE 10 ML, 10 MLS, 20 ML, 3 ML, 30 ML, 4 ML, 40 ML, 5 ML, 6 ML; ALPROSTADIL 24MCG/ML INJECTABLE 6 ML; ALPROSTADIL 25MCG/ML INJECTABLE 10 ML; ALPROSTADIL 30MCG/ML INJECTABLE 10 ML; ALPROSTADIL 35MCG/ML INJECTABLE 10 ML; ALPROSTADIL 40MCG/ML INJECTABLE 10 ML, 10 ML, 10 VIAL, 15 ML, 2 ML, 20 ML, 3 ML, 30 ML, 40 ML, 5 ML, 50 ML, 6 ML; ALPROSTADIL 50MCG/ML INJECTABLE 10 ML, 2 ML, 20 ML, 5 ML; ALPROSTADIL 60MCG/ML INJECTABLE 20 ML; ALPROSTADIL (M) 500MCG/ML INJECTABLE 10 ML; ALPROSTADIL 100MCG/ML INJECTABLE 5 ML; ALPROSTADIL, STERILE 1,000MCG/ML GEL 10 ML, 12 ML, 20 ML, 3 ML, 30 ML, 6 ML; ALPROSTADIL/PAPAVERINE 10MCG/9MG/ML INJECTABLE; ALPROSTADIL/PHENT 10MCG/0.5MG/ML INJECTABLE 10 ML, 5 ML; ALPROSTADIL/PHENT 17MCG/0.5MG/ML INJECTABLE 10 ML; ALPROSTADIL/PHENTOLAMINE 40MCG/2MG/ML INJECTABLE 10 ML (50 DIFFERENT PRODUCTS) Rx #'s: 0358246, 0364805, 0368284, 0378756, 0380820, 0387648, 0388175, 0388294, 0388761, 0391370, 0393218, 0393296, 0394349, 0394946, 0395082, 0395861, 0396187, 0398267, 0401319, 0404291, 0405612, 0388186, 0399034, 0386335, 0400431, 0407531, 0358246, 0378756, 0388743, 0400047, 0404363, 0388082, 0409372, 0348455, 0350663, 0353518, 0355129, 0355693, 0356375, 0357470, 0357616, 0358082, 0358244, 0358434, 0359158, 0363285, 0365259, 0367960, 0369601, 0370844, 0370856, 0371600, 0372364, 0373144, 0373375, 0373510, 0374111, 0374998, 0375459, 0375602, 0376024, 0376332, 0376872, 0377260, 0377875, 0377985, 0379138, 0379565, 0381219, 0383350, 0383828, 0383945, 0385030, 0386074, 0386125, 0386686, 0386742, 0387013, 0387677, 0387846, 0387958, 0388044, 0388436, 0388779, 0388809, 0389393, 0389418, 0389598, 0390069, 0390100, 0390105, 0390505, 0390514, 0390727, 0390999, 0391218, 0391382, 0391595, 0391844, 0391948, 0391988, 0392128, 0392227, 0392536, 0392693, 0392724, 0393539, 0393726, 0393837, 0393890, 0394052, 0394339, 0394442, 0394610, 0394740, 0394779, 0394933, 0395044, 0395610, 0396031, 0396423, 0396428, 0396488, 0396514, 0396850, 0396858, 0396885, 0397148, 0397215, 0397247, 0397393, 0397721, 0397747, 0398357, 0398790, 0398832, 0399045, 0399061, 0399186, 0399368, 0399512, 0399565, 0399867, 0400110, 0400648, 0400692, 0401141, 0401171, 0401436, 0401685, 0401963, 0402524, 0402833, 0402836, 0403131, 0403599, 0403651, 0403776, 0404125, 0404206,0404594,0405337, 0405746, 0406186, 0406350, 0406503, 0406533, 0406608, 0406961, 0407011, 0407522, 0407608, 0408149, 0408243, 0408471, 0408475, 0408733, 0408803, 0408948, 0409227, 0409652, 0408211, 0370597, 0372090, 0372291, 0377260, 0383350, 0384600, 0386742, 0387759, 0394740, 0395554, 0398507, 0399696, 0400665, 0407851, 0384600, 0390561, 0390730, 0391280, 0404039, 0398586, 0387759, 0363140, 0373946, 0379198, 0381414, 0388131, 0390621, 0391087, 0396493, 0402322, 0406179, 0406683, 0407311, 0407850, 0408048, 0392605, 0378371, 0388907, 0391868, 0390192, 0396500, 0352172, 0357035, 0358183, 0358360, 0360788, 0366242, 0366923, 0368523, 0369902, 0374538, 0375333, 0375959, 0377935, 0378040, 0378351, 0379207, 0381237, 0382171, 0385235, 0386937, 0387960, 0388158, 0388210, 0388404, 0388444, 0388445, 0388596, 0388605, 0389108, 0389341, 0389709, 0390347, 0390351, 0390846, 0391197, 0391199, 0391635, 0391700, 0391753, 0392003, 0392022, 0392047, 0392213, 0392423, 0392641, 0392690, 0393922, 0394131, 0394193, 0394388, 0394635, 0394718, 0394798, 0395372, 0395626, 0395876, 0396249, 0396718, 0397811, 0398107, 0398194, 0398343, 0398844, 0398887, 0398982, 0399110, 0399320, 0399528, 0399765, 0400046, 0400096, 0400297, 0400421, 0400424, 0400598, 0400913, 0401400, 0401500, 0401680, 0401934, 0402088, 0402325, 0402328, 0402586, 0402967, 0403274, 0403345, 0403607, 0404401, 0405474,0405498, 0405724, 0406291, 0406457, 0406542, 0407511, 0408231, 0409030, 0409062, 0409526, 0409607, 0409759, 0410307, 0393753, 0397762, 0403540, 0374221, 0382214, 0395621, 0397852, 0402288, 0406445, 0399687, 0374221, 0366701, 0351976, 0354103, 0384453, 0390423, 0391629, 0393615, 0396582, 0397827, 0398720, 0399013, 0403466, 0406583, 0409862, 0397208, 0361392, 0379145, 0380920, 0387005, 0400616, 0404590, 0404931, 0396725, 0392873, 0357803, 0363807, 0365784, 0370228, 0372609, 0376996, 0377620, 0378319, 0380457, 0381999, 0382394, 0382527, 0382743, 0382990, 0386135, 0386929, 0387451, 0387674, 0389081, 0389143, 0389875, 0390000, 0390409, 0391030, 0391711, 0392245, 0392563, 0392705, 0392767, 0393396, 0393794, 0394466, 0395061, 0396510, 0397503, 0397715, 0397737, 0397916, 0397953, 0398923, 0399635, 0399757, 0399812, 0400282, 0400880, 0402467, 0403426, 0403519, 0403728, 0403832, 0404015, 0404522, 0405565, 0405585, 0406128, 0406628, 0407265, 0407357, 0407736, 0407839, 0408178, 0408378, 0409610, 0409944, 0388717, 0394665, 0367237, 0368886, 0401105, 0395886, 0397863, 0388295, 0387427, 0388295, 0397030 Class II Lack of Assurance of Sterility: Franck's Lab Inc. initiated a recall of all Sterile Human Drugs distributed between 11/21/2011 and 05/21/2012 because FDA environmental sampling revealed the presence of microorganisms and fungal growth in the clean room where sterile products were prepared. Franck's Lab Inc., d.b.a. Franck's Compounding Lab
Drugs ALTEPLASE, SDPF - (0.05ML SYRINGE, 30G, 1/2") 1000MCG/ML INJECTABLE 0.05 ML; ALTEPLASE, SDPF - (0.15ML LL SYRINGE, NO NEEDLE) 100MCG/ML (10MCG/0.1ML) INJECTA 0.15 ML, 0.3 ML; ALTEPLASE, SDPF - (0.1ML SYRINGE, 30G, 1/2") 1000MCG/ML INJECTABLE 0.1 ML, 0.2 ML, 0.3 ML; ALTEPLASE, SDPF - (0.1ML SYRINGE, 30G, 1/2") 100MCG/ML (10MCG/0.1ML) INJECTABLE 0.1 ML, 0.3 ML; ALTEPLASE, SDPF - (0.1ML SYRINGE, 30G, 1/2") 250MCG/ML (25MCG/0.1ML) INJECTABLE 0.1 ML (9 DIFFERENT PRODUCTS) Rx #'s: 0392878, 0398614, 0394932, 0394932, 0387461, 0352013, 0391247, 0391792, 0399973, 0401614, 0402893, 0392721, 0392721, 0382234 Class II Lack of Assurance of Sterility: Franck's Lab Inc. initiated a recall of all Sterile Human Drugs distributed between 11/21/2011 and 05/21/2012 because FDA environmental sampling revealed the presence of microorganisms and fungal growth in the clean room where sterile products were prepared. Franck's Lab Inc., d.b.a. Franck's Compounding Lab
Drugs AMINOPHYLLINE 20ML, SDV** 500MG (25MG/ML) INJECTABLE 20 ML (1 PRODUCT) Rx #: 0390157 Class II Lack of Assurance of Sterility: Franck's Lab Inc. initiated a recall of all Sterile Human Drugs distributed between 11/21/2011 and 05/21/2012 because FDA environmental sampling revealed the presence of microorganisms and fungal growth in the clean room where sterile products were prepared. Franck's Lab Inc., d.b.a. Franck's Compounding Lab
Drugs AMPHOTERICIN B OPHTHALMIC (0.5ML, LL SYRINGE) P.F. 10MCG/0.1ML INJECTABLE 1 ML, 1.5 ML, 2 ML, 2.5 ML, 5 ML; AMPHOTERICIN B OPHTHALMIC 5MCG/0.1ML INJECTABLE, 0.2 ML, 0.4 ML, 3 ML; AMPHOTERICIN B, LYOPHILIZED 150MCG INJECTABLE 2 VIAL; AMPHOTERICIN-B, NEBULIZATION, STERILE 5MG/2ML NASO-NEB 60 ML (10 DIFFERENT PRODUCTS) Rx #'s: 0404547, 0404385, 0410167, 0410170, 0410171, 0404102, 0404102, 0404547, 0380221, 0373088, 0398747, 0390360, 0402572 Class II Lack of Assurance of Sterility: Franck's Lab Inc. initiated a recall of all Sterile Human Drugs distributed between 11/21/2011 and 05/21/2012 because FDA environmental sampling revealed the presence of microorganisms and fungal growth in the clean room where sterile products were prepared. Franck's Lab Inc., d.b.a. Franck's Compounding Lab
Drugs ASCORBIC ACID (BEET SOURCE) 500MG/ML INJECTABLE 100 ML, 150 ML, 200 ML, 250 ML, 300 ML, 400 ML, 500 ML, 60 ML; ASCORBIC ACID (CORN SOURCE) 500MG/ML INJECTABLE 100 ML; ASCORBIC ACID, 50ML SDPF, VIAL** 500MG/ML INJECTABLE 50 ML, 500 ML; ASCORBIC/B1/B2/B3/B5/B6/B12/METHIONINE/INOSITOL/CHOLINE/LIDO INJECTABLE 40 ML, 50 ML, 60 ML (14 DIFFERENT PRODUCTS) Rx #'s: 0388808, 0406214, 0388808, 0406214, 0388808, 0388808, 0388808, 0406214, 0400763, 0402158, 0393558, 0393558, 0394256 Class II Lack of Assurance of Sterility: Franck's Lab Inc. initiated a recall of all Sterile Human Drugs distributed between 11/21/2011 and 05/21/2012 because FDA environmental sampling revealed the presence of microorganisms and fungal growth in the clean room where sterile products were prepared. Franck's Lab Inc., d.b.a. Franck's Compounding Lab
Drugs ATROPINE SULFATE 0.4MG/ML INJECTABLE 12 ML, 2 ML, 20 ML, 24 ML, 25 ML, 3 ML; ATROPINE/EPINEPHRINE/ BSS 0.02MG/0.1MG/ML INJECTABLE 10 ML, 5 ML (8 DIFFERENT PRODUCTS) Rx #'s: 0398523, 0404345, 0404347, 0404348, 0404349, 0404351, 0406460, 0384921, 0395199, 0399779, 0379708, 0395199, 0389329, 0409506, 0378436 Class II Lack of Assurance of Sterility: Franck's Lab Inc. initiated a recall of all Sterile Human Drugs distributed between 11/21/2011 and 05/21/2012 because FDA environmental sampling revealed the presence of microorganisms and fungal growth in the clean room where sterile products were prepared. Franck's Lab Inc., d.b.a. Franck's Compounding Lab
Drugs BACLOFEN, P.F. (WITH 0.9% P.F. NORMAL SALINE) 2,000MCG/ML (2MG/ML) INTRATHECAL 40 ML; BACLOFEN, P.F. (WITH 0.9% P.F. NORMAL SALINE) 600MCG/ML INTRATHECAL 40 ML; BACLOFEN, P.F. 1,000MCG/ML (1MG/ML) INTRATHECAL 20 ML, 40 ML; BACLOFEN, P.F. 500MCG/ML (0.5MG/ML) INTRATHECAL 40 ML; BACLOFEN, PRESERVATIVE FREE 3000MCG/ML INJECTABLE 40 ML; BACLOFEN, PRESERVATIVE FREE 3300MCG/ML(3.3MG/ML) INTRATHECAL 20 ML; BACLOFEN, PRESERVATIVE FREE 5000MCG/ML(5MG/ML) INTRATHECAL 40 ML (8 DIFFERENT PRODUCTS) Rx #'s: 0406446, 0404313, 0381309, 0390603, 0350228, 0389240, 0365111, 0383582, 0391840, 0399130, 0372385, 0387886, 0406914 Class II Lack of Assurance of Sterility: Franck's Lab Inc. initiated a recall of all Sterile Human Drugs distributed between 11/21/2011 and 05/21/2012 because FDA environmental sampling revealed the presence of microorganisms and fungal growth in the clean room where sterile products were prepared. Franck's Lab Inc., d.b.a. Franck's Compounding Lab
Drugs BACLOFEN/BUPIVACAINE/CLONIDINE/MORPHINE, P.F. 1000MCG/7.5MG/1000MCG/50MG/ML INTR 40 ML; BACLOFEN/BUPIVACAINE/CLONIDINE/MORPHINE, P.F. 50MCG/2MG/200MCG/50MG/ML INTRATHEC 18 ML; BACLOFEN/CLONIDINE/BUPIVACAINE/MORPHINE, P.F. 500MCG/1/7.5/50MG/ML INTRATHECAL 40 ML (3 DIFFERENT PRODUCTS) Rx #'s:N0406290, N0387600, N0390988, N0393344, N0396645, N0400013, N0403729, N0406665, N0410203, N0393490 Class II Lack of Assurance of Sterility: Franck's Lab Inc. initiated a recall of all Sterile Human Drugs distributed between 11/21/2011 and 05/21/2012 because FDA environmental sampling revealed the presence of microorganisms and fungal growth in the clean room where sterile products were prepared. Franck's Lab Inc., d.b.a. Franck's Compounding Lab
Drugs BACLOFEN/HYDROMORPHONE, P.F. 2000MCG/2.9MG/ML INTRATHECAL 20 ML; BACLOFEN/HYDROMORPHONE, P.F. 2000MCG/6MG/ML INTRATHECAL 40 ML; BACLOFEN/HYDROMORPHONE, P.F. 500MCG/50MG/ML INTRATHECAL 40 ML (2 DIFFERENT PRODUCTS) Rx #'s:N0407992, N0387607, N0394440, N0402003, N0409979, N0399632 Class II Lack of Assurance of Sterility: Franck's Lab Inc. initiated a recall of all Sterile Human Drugs distributed between 11/21/2011 and 05/21/2012 because FDA environmental sampling revealed the presence of microorganisms and fungal growth in the clean room where sterile products were prepared. Franck's Lab Inc., d.b.a. Franck's Compounding Lab
Drugs BACLOFEN/MORPHINE, P.F. 1,000MCG/25MG/ML INTRATHECAL 18 ML; BACLOFEN/MORPHINE, P.F. 1,500MCG/1.5MG/ML INTRATHECAL 40 ML; BACLOFEN/MORPHINE, P.F. 2,000MCG/25MG/ML INTRATHECAL 40 ML (3 DIFFERENT PRODUCTS) Rx #'s:N0392050, N0391605, N0402936 Class II Lack of Assurance of Sterility: Franck's Lab Inc. initiated a recall of all Sterile Human Drugs distributed between 11/21/2011 and 05/21/2012 because FDA environmental sampling revealed the presence of microorganisms and fungal growth in the clean room where sterile products were prepared. Franck's Lab Inc., d.b.a. Franck's Compounding Lab
Drugs BEVACIZUMAB & DXM, SDPF - (0.06ML SYRINGE, 31G, 5/16") 25MG/100MG/ML INJECTABLE 0.72 ML; BEVACIZUMAB & DXM, SDPF - (0.06ML SYRINGE, 31G, 5/16") 25MG/20MG/ML INJECTABLE 3 ML, 4.5 ML; BEVACIZUMAB & DXM, SDPF - (0.075ML SYRINGE, 30G, 1/2") 25MG/20MG/ML INJECTABLE 0.225 ML; BEVACIZUMAB & DXM, SDPF - (0.07ML SYRINGE, 30G, 1/2") 25MG/20MG/ML INJECTABLE 0.07 ML, 1.33 ML, 1.4 ML, 1.47 ML; BEVACIZUMAB & DXM, SDPF - (0.07ML SYRINGE, 30G, 1/2") 25MG/40MG/ML INJECTABLE 0.35 ML, 0.7 ML, 1.05 ML; BEVACIZUMAB & DXM, SDPF - (0.07ML SYRINGE, NO NEEDLE) 25MG/40MG/ML INJECTABLE 0.63 ML; BEVACIZUMAB & DXM, SDPF - (0.09ML SYRINGE, 30G, 1/2") 25MG/20MG/ML INJECTABLE 1.8 ML, 2.7 ML; BEVACIZUMAB & DXM, SDPF - (0.09ML SYRINGE, 31G, 5/16") 25MG/20MG/ML INJECTABLE 0.18 ML, 0.27 ML, 0.45 ML, 1.08 ML, 13.5 ML,2.25 ML, 4.5 ML; BEVACIZUMAB & DXM, SDPF - (0.1ML SYRINGE, 30G, 1/2") 25MG/16MG/ML INJECTABLE 0.3 ML, 0.4 ML, 0.5 ML, 1 ML, 1.2 ML, 1.5 ML, 2 ML, 2.5 ML, 5 ML, 7.5 ML; BEVACIZUMAB & DXM, SDPF - (0.1ML SYRINGE, 30G, 1/2") 25MG/40MG/ML INJECTABLE 4 ML, 6 ML; BEVACIZUMAB & DXM, SDPF - (0.1ML SYRINGE, 31G, 5/16") 25MG/16MG/ML INJECTABLE 2 ML, 2.5 ML; BEVACIZUMAB & DXM, SDPF - (0.1ML SYRINGE, 31G, 5/16") 25MG/20MG/ML INJECTABLE 0.3 ML, 0.4 ML, 0.5 ML, 0.6 ML, 0.7 ML, 0.8 ML, 1 ML, 1.5 ML, 55.1 ML, 57.5 ML, 57.6 ML, 58 ML, 7.5 ML; BEVACIZUMAB & DXM, STSL (0.1ML SYRINGE, 30G, 1/2") 25MG/16MG/ML INJECTABLE 0.3 ML; BEVACIZUMAB & TMC, SDPF - (0.075ML SYRINGE, 30G 1/2") 25MG/40MG/ML INJECTABLE 0.075 ML, 0.15 ML, 0.225 ML, 0.375 ML, 0.75 ML, 1.125 ML, 1.5 ML; BEVACIZUMAB & TMC, SDPF (0.075ML SYRINGE, 30G, 1/2") 25MG/80MG/ML INJECTABLE 0.45 ML, 0.75 ML; BEVACIZUMAB & TMC, SDPF - (0.1ML SYRINGE, 30G, 1/2") 25MG/40MG/ML INJECTABLE 0.3 ML, 0.5 ML, 1 ML, 2 ML, 2.5 ML, 3 ML; BEVACIZUMAB & TMC, SDPF - (0.1ML SYRINGE, NO NEEDLE) 25MG/40MG/ML INJECTABLE 0.5 ML; BEVACIZUMAB & TMC, SDPF W/ STSL - (0.075ML SYRINGE, 30G, 1/2") 25MG/80MG/ML INJE 0.375 ML, 0.525 ML, 0.75 ML, 1.125 ML; BEVACIZUMAB & TMC, SDPF W/ STSL - (0.15ML SYRINGE, 30G, 1/2") 25MG/40MG/ML INJEC 0.6 ML, 0.75 ML, 0.9 ML, 1.05 ML; BEVACIZUMAB & TMC, SDPF W/ STSL - (0.1ML SYRINGE, 30G, 1/2") 25MG/20MG/ML INJECT 0.2 ML, 0.4 ML; BEVACIZUMAB & TMC, SDPF W/ STSL - (0.1ML SYRINGE, 30G, 1/2") 25MG/40MG/ML INJECT 0.6 ML, 1 ML; BEVACIZUMAB IN ARTIFICIAL TEARS 0.5% (5MG/ML) OPHTHALMIC 5 ML; BEVACIZUMAB, SDPF - (0.05ML SYRINGE, 27G, 1/2") 25MG/ML INJECTABLE 0.3 ML; BEVACIZUMAB, SDPF - (0.05ML SYRINGE, 30G, 1/2") 25MG/ML INJECTABLE 0 MLS, 0.05 ML, 0.1 ML, 0.15 ML, 0.2 ML, 0.2 MLS, 0.25 ML, 0.25 MLS, 0.3 ML, 0.3 MLS, 0.35 ML, 0.36 ML, 0.4 ML, 0.45 ML, 0.5 ML, 0.6 ML, 0.65 ML, 0.7 ML, 0.75 ML, 0.8 ML, 1 ML, 1.2 ML, 1.25 ML, 1.5 ML,1.5 MLS, 1.75 ML, 1.8 ML, 10 ML, 15 ML, 2 ML, 2.25 ML, 2.5 ML, 2.5 MLS, 2.55 ML, 2.6 ML, 3 ML, 3.1 ML, 3.5 ML, 3.6 ML, 3.65 ML, 3.7 ML, 3.75 ML, 3.96 MLS, 4 ML, 4.5 ML, 5 ML, 5 MLS, 7 ML, 7.2 ML, 7.2 MLS, 7.25 ML, 7.3 MLS, 7.3 VIAL, 7.4 MLS, 7.5 ML; BEVACIZUMAB, SDPF - (0.05ML SYRINGE, 31G, 5/16") 25MG/ML INJECTABLE 0.1 ML, 0.15 ML, 0.2 ML, 0.25 ML, 0.3 ML, 0.35 ML, 0.4 ML, 0.5 ML, 0.55 ML, 0.6 ML, 0.65 ML, 0.7 ML, 0.75 ML, 0.8 ML, 0.85 ML, 0.9 ML, 1 ML, 1.1 ML, 1.2 ML, 1.25 ML, 1.5 ML, 1.75 ML, 10 ML, 12.25 ML, 12.5 ML, 13.5 ML, 15 ML, 17.5 ML, 2 ML, 2.25 ML, 2.5 ML, 2.6 ML, 3 ML, 3.5 ML, 3.75 ML, 4 ML, 4.5 ML, 5 ML, 5.05 ML, 6 ML, 6.25 ML, 6.35 ML, 7.5 ML, 8.75 ML; BEVACIZUMAB, SDPF - (0.06ML SYRINGE, 30G, 1/2") 25MG/ML INJECTABLE 1.2 ML, 2.88 ML; BEVACIZUMAB, SDPF - (0.06ML SYRINGE, 31G, 5/16") 25MG/ML INJECTABLE 1.5 ML, 1.8 ML, 2.4 ML, 3 ML, 3.6 ML, 4.8 ML, 6 ML; BEVACIZUMAB, SDPF - (0.07ML SYRINGE, 30G, 1/2") 25MG/ML INJECTABLE 1.75 ML; BEVACIZUMAB, SDPF - (0.07ML SYRINGE, 31G, 5/16") 25MG/ML INJECTABLE 0.14 ML, 0.21 ML, 1.75 ML, 3.5 ML, 4.2 ML, 5.6 ML, 7 ML; BEVACIZUMAB, SDPF - (0.08ML SYRINGE, 30G, 1/2") 25MG/ML INJECTABLE 0.08 ML; BEVACIZUMAB, SDPF - (0.08ML SYRINGE, NO NEEDLE) 25MG/ML INJECTABLE 0.08 ML, 0.16 ML, 0.24 ML, 0.32 ML, 0.48 ML, 16 ML, 8 ML; BEVACIZUMAB, SDPF - (0.12ML SYRINGE, 30G, 1/2") 25MG/ML INJECTABLE 1.08 ML, 1.2 ML, 1.8 ML, 3.6 ML; BEVACIZUMAB, SDPF - (0.12ML SYRINGE, NO NEEDLE) 25MG/ML INJECTABLE 12 ML, 18 ML, 19.2 ML, 20.4 ML, 22.2 ML, 24 ML, 6 ML, 9 ML, 9.6 ML; BEVACIZUMAB, SDPF - (0.16ML SYRINGE, 30G, 1/2") 25MG/ML INJECTABLE 3.2 ML, 4.8 ML; BEVACIZUMAB, SDPF - (0.1ML SYRINGE, 27G, 1/2") 25MG/ML INJECTABLE 2.5 ML, 3 ML, 3.5 ML, 4 ML, 5 ML, 5.5 ML; BEVACIZUMAB, SDPF - (0.1ML SYRINGE, 30G, 1/2") 25MG/ML INJECTABLE 0.1 ML, 0.2 ML, 0.3 ML, 1 ML, 2 ML, 3 ML, 4 ML; BEVACIZUMAB, SDPF - (0.1ML SYRINGE, 31G 5/16") 25MG/ML INJECTABLE 0.1 ML, 0.6 ML, 1 ML; BEVACIZUMAB, SDPF - (0.1ML SYRINGE, NO NEEDLE) 25MG/ML INJECTABLE 0.5 ML, 2 ML, 3 ML; BEVACIZUMAB, STSL - (0.05ML SYRINGE, 30G, 1/2") 25MG/ML INJECTABLE 0.05 ML, 0.25 ML, 0.5 ML, 0.6 ML, 0.8 ML, 0.95 ML,1 ML, 1.05 ML, 1.2 ML, 1.25 ML, 1.5 ML, 1.8 ML, 1.9 ML, 10 ML, 2 ML, 2.05 ML, 2.25 ML, 3 ML, 3.5 ML, 4 ML, 5 ML; BEVACIZUMAB, STSL - (0.05ML SYRINGE, 30G, 3/8") 25MG/ML INJECTABLE 1 ML, 1.05 ML, 1.5 ML; BEVACIZUMAB, STSL - (0.05ML SYRINGE, 31G, 5/16") 25MG/ML INJECTABLE 0.05 ML, 0.1 ML, 0.15 ML, 0.5 ML, 0.6 ML, 0.75 ML, 1 ML, 1.05 ML, 1.2 ML, 1.25 ML, 1.5 ML, 2 ML, 2.5 ML, 2.75 ML, 3 ML, 3.15 ML, 3.75 ML, 5 ML, 5.5 ML, 6.5 ML, 7.5 ML; BEVACIZUMAB, STSL - (0.1ML SYRINGE, NO NEEDLE) 25MG/ML INJECTABLE 1.2 ML, 1.5 ML, 1.8 ML, 2.1 ML, 2.4 ML (297 DIFFERENT PRODUCTS) Rx #'s: 0359160 0405079 0364389 0364389 0361241 0377683 0377683 0377683 0377683 0401661 0401661 0401661 0390308 0359300 0404762 0382630 0407996 0361441 0407996 0387326 0398781 0356812 0398781 0356812 0375792 0403341 0375792 0399708 0387144 0399708 0387144 0375792 0353919 0375792 0389701 0357461 0387144 0389701 0397437 0352503 0357461 0377580 0377580 0386958 0386958 0367201 0371279 0371279 0367201 0384322 0371279 0384322 0367201 0384322 0384322 0375486 0375486 0375486 0375486 0390996 0381779 0361290 0391677 0403321 0361290 0403321 0397396 0393484 0401740 0390929 0393759 0384195 0388799 0388805 0393759 0388805 0393484 0387836 0387836 0398119 0350119 0359128 0400639 0353914 0394457 0353914 0382205 0353914 0394457 0382205 0393293 0393299 0393300 0399578 0399598 0390926 0393485 0388801 0393485 0388806 0368969 0368969 0390918 0390918 0390918 0392167 0357998 0402352 0393760 0393760 0356752 0401186 0369338 0380167 0367010 0369225 0384207 0385361 0387698 0394363 0395273 0396614 0398024 0398662 0399938 0403502 0408817 0359129 0367010 0367401 0370758 0370759 0370763 0370767 0370768 0370770 0370778 0370779 0370783 0370785 0374018 0374024 0374028 0374036 0379772 0379773 0379774 0387698 0388817 0396342 0407944 0407945 0407946 0408269 0408741 0408742 0408817 0370141 0370142 0371173 0371773 0373627 0376439 0378889 0378890 0378892 0378894 0378897 0378898 0378899 0382662 0382666 0382667 0382669 0382670 0382674 0382919 0383307 0383314 0383346 0385937 0388305 0396302 0399567 0401360 0407944 0407945 0407946 0407948 0407951 0407955 0408233 0408237 0408242 0408248 0408250 0408251 0408259 0408262 0408264 0408265 0408271 0408272 0408274 0408280 0408281 0408284 0408672 0408673 0408674 0408675 0408676 0408677 0408678 0408679 0408680 0408681 0408682 0408683 0408684 0408685 0409171 0409173 0409188 0409191 0409205 0409207 0409825 0409826 0409827 0409828 0409829 0409830 0409831 0352123 0359738 0376439 0384103 0385937 0388817 0401360 0401986 0367896 0355412 0359738 0360220 0371173 0372305 0372673 0375789 0378673 0388774 0391407 0392221 0396687 0400615 0404394 0409879 0409880 0367896 0354585 0372673 0375616 0376439 0377592 0380869 0388817 0389473 0390204 0391693 0392559 0396781 0397261 0397948 0398535 0399761 0401997 0367896 0349959 0350509 0365293 0367347 0369312 0371910 0372413 0373066 0373071 0375917 0375918 0376390 0378853 0385894 0387469 0387471 0387472 0388125 0388126 0388128 0388133 0388136 0388635 0389211 0389215 0390369 0390839 0390843 0390848 0391153 0391338 0391340 0391763 0391764 0391861 0391864 0392979 0393223 0394391 0394393 0394501 0394502 0394707 0395314 0395316 0396363 0396818 0396827 0396829 0397889 0397893 0398006 0398551 0398553 0399238 0399240 0399488 0399489 0399502 0399891 0399892 0399893 0399894 0401526 0401528 0402863 0403606 0403609 0403611 0403785 0404539 0404540 0405532 0405933 0406247 0375916 0366046 0366486 0378138 0380869 0386460 0388817 0394444 0398535 0401997 0409796 0378138 0398535 0354936 0355412 0359129 0359985 0360220 0363258 0365502 0367016 0367501 0368624 0371173 0372081 0373976 0375616 0377592 0378673 0382974 0383654 0386404 0387739 0388288 0388774 0388785 0389473 0389828 0392521 0392818 0394444 0398535 0402803 0403654 0404459 0405383 0408232 0409453 0350698 0355237 0366486 0368624 0371173 0378138 0384670 0385775 0388288 0391887 0393789 0396687 0388817 0366486 0356702 0359129 0360220 0367016 0375789 0378673 0382974 0384849 0386404 0387740 0388288 0389473 0390219 0397948 0398337 0398805 0354554 0359129 0388817 0352916 0352996 0354554 0359129 0359985 0361041 0362197 0363258 0365502 0366486 0367016 0367240 0368282 0368624 0371184 0375789 0378583 0378823 0379513 0380679 0382974 0383438 0384676 0384849 0386729 0387024 0387168 0387740 0388154 0388785 0389511 0391887 0392445 0393797 0399912 0400472 0400522 0401225 0405018 0409004 0409245 0379513 0385775 0352372 0361666 0365188 0365502 0366619 0368282 0378583 0378911 0382974 0385549 0387024 0387374 0387420 0389828 0392938 0394683 0397164 0405238 0408232 0349177 0350459 0352916 0354764 0358804 0359985 0363966 0368493 0371184 0378583 0380167 0385014 0385036 0385549 0387024 0387168 0387334 0387374 0387739 0388080 0388154 0388288 0388561 0389828 0390176 0390219 0391013 0392187 0392445 0393559 0394572 0398217 0401225 0402280 0403944 0405665 0407685 0409157 0380167 0354764 0378583 0387024 0387374 0398602 0379513 0390966 0382620 0390262 0390262 0350302 0357190 0360145 0366591 0378823 0380999 0383438 0384207 0384676 0384713 0385014 0385036 0387024 0387739 0388561 0391007 0391265 0391768 0398602 0407622 0409004 0376772 0406033 0351645 0353827 0355623 0360220 0360607 0361078 0361666 0363966 0366600 0366619 0368316 0378911 0380061 0380658 0384676 0384713 0384923 0387739 0390060 0390223 0390262 0392818 0395368 0397164 0398337 0399928 0402827 0405238 0408166 0408815 0380323 0387420 0380061 0353827 0355819 0357190 0361868 0366591 0373924 0378823 0380999 0383438 0387168 0392868 0395368 0399063 0400380 0405406 0408666 0409004 0361868 0353827 0365737 0365737 0389735 0365737 0365737 0380167 0361666 0387815 0380167 0357190 0373924 0380999 0388167 0387488 0352821 0352950 0354664 0365296 0366374 0373924 0380658 0384676 0384923 0385412 0386588 0388167 0390060 0390223 0390262 0394454 0394514 0396082 0399081 0380323 0364967 0399540 0402861 0373924 0380167 0380167 0380167 0380167 0380167 0365296 0386588 0408941 0391001 0396063 0396064 0396069 0396072 0396074 0396076 0406966 0367119 0367128 0367144 0367162 0367167 0367168 0368589 0368907 0370072 0370538 0371351 0373487 0376100 0376101 0376102 0376108 0377388 0377390 0377391 0377639 0378635 0378637 0384407 0400209 0408467 0408474 0408482 0408922 0408924 0408926 0408945 0408955 0408957 0408958 0408959 0408960 0408963 0408965 0408968 0408969 0408971 0408973 0408975 0408976 0408979 0408981 0408982 0408985 0408986 0408988 0409360 0409362 0409363 0409365 0409367 0409368 0409370 0409371 0409455 0409456 0409460 0409462 0409466 0409467 0409469 0409470 0409473 0409474 0409475 0409476 0409478 0409479 0409480 0409481 0409482 0409483 0409485 0409486 0409992 0409995 0409996 0409997 0410009 0379496 0379497 0382688 0384407 0394883 0394892 0394894 0367009 0371356 0379346 0384407 0387817 0367009 0395420 0380864 0362676 0391416 0360422 0367009 0368228 0371356 0379166 0379346 0380864 0382774 0386513 0388038 0389912 0390124 0391416 0394138 0400209 0404461 0380864 0368228 0384722 0387051 0380864 0380864 0350991 0357056 0361676 0365399 0367009 0368228 0377761 0380864 0384722 0386513 0390124 0394138 0394380 0394654 0368228 0380864 0404786 0390124 0387051 0349046 0349527 0352252 0360448 0364804 0365399 0366800 0368585 0371356 0372632 0375719 0377761 0379346 0380567 0380758 0380864 0381539 0384722 0387508 0387817 0389697 0389912 0390124 0390147 0392169 0393206 0393526 0394312 0394380 0394654 0396688 0402930 0404374 0393206 0387051 0391416 0392169 0363706 0364338 0371356 0382947 0384722 0392169 0406187 0407176 0349333 0362957 0363706 0368581 0370372 0371356 0377761 0380754 0381076 0382339 0384722 0388038 0389046 0390124 0391060 0392169 0393761 0394015 0394312 0396688 0406070 0380505 0389046 0354566 0356480 0358943 0373161 0399623 0391272 0399623 0391272 0385261 0386746 0385261 0363706 0366800 0366802 0368581 0368585 0371356 0380754 0381539 0382339 0388038 0388856 0389371 0390147 0393761 0394312 0398208 0380505 0398208 0363706 0363778 0364338 0366802 0368581 0369332 0378667 0381748 0382339 0385261 0388038 0388530 0388856 0389697 0403307 0405316 0408287 0388856 0361320 0363706 0366802 0381076 0404496 0366802 0381076 0363706 0369332 0381076 0381748 0406528 0389697 0370372 0358943 0368879 0369332 0370372 0378279 0386285 0386631 0387440 0389697 0401843 0406187 0409595 0386285 0386631 0368879 0366903 0401843 0378279 0356077 0358943 0366903 0367878 0378279 0399290 0358943 0366903 0373461 0386366 0391318 0386239 0386239 0391318 0369515 0381033 0399529 0381033 0369515 0382083 0408575 0410038 0408545 0408548 0408549 0408551 0408552 0408556 0408557 0408559 0408561 0408562 0408563 0408564 0408566 0408567 0408568 0408572 0410000 0410003 0410005 0410006 0410010 0410011 0410012 0410013 0410014 0410021 0410023 0410026 0410027 0410032 0410035 0410036 0384698 0374276 0384698 0359109 0359109 0385519 0357253 0369326 0371914 0379256 0362070 0389165 0389174 0389559 0390877 0406656 0375624 0389043 0390877 0395563 0398015 0402663 0405680 0409170 0409331 0360751 0363002 0375624 0389165 0389469 0390962 0392527 0393758 0395160 0395382 0396588 0396772 0397371 0406507 0407078 0410316 0349549 0354136 0392052 0392052 0386359 0391609 0391609 0384742 0390822 0390822 0390822 0385919 0385919 0385919 0390822 0390822 0401752 0401752 0389208 0389208 0353398 0353398 0395793 0395793 0395793 0395793 0408132 0362868 0362868 0408092 0408098 0408104 0408106 0408108 0408109 0408112 0408121 0408123 0408125 0408126 0408127 0408131 0408270 0388851 0390649 0401777 0356392 0380680 0388851 0400670 0384734 0386866 0367047 0367047 0368258 0387412 0387412 0389503 0406922 0366709 0384829 0366709 0384845 0357997 0389503 0366709 0389503 0390475 0406922 0402353 0384845 0386279 0387641 0360671 0389503 0387641 0368967 0361445 0405294 0368967 0387641 0389503 0389503 0368967 0369511 0386279 0393604 0369511 0369511 0393604 0361445 0390391 0390391 0391674 0367965 0374654 0379809 0379812 0379814 0379823 0388302 0388304 0394315 0394316 0394317 0394318 0394319 0394320 0394321 0394322 0394323 0394324 0394325 0394326 0394327 0394328 0394329 0394330 0394331 0394334 0394335 0394336 0394337 0396752 0396755 0396757 0396760 0396761 0396786 0396788 0396791 0396795 0396796 0396799 0396800 0396811 0396812 0396819 0396832 0396834 0396838 0396839 0401284 0401285 0401286 0401287 0401288 0401289 0401290 0401291 0401292 0401293 0401294 0401295 0401296 0401308 0401309 0401311 0401314 0401315 0403881 0403882 0403884 0403885 0403886 0403887 0403888 0403890 0403891 0403892 0403893 0403894 0403895 0403896 0403897 0403898 0403901 0403902 0403903 0403904 0403905 0403907 0403908 0403909 0403910 0409124 0409125 0409126 0409127 0409129 0409131 0379823 0396780 0396793 0396809 0396831 0402979 0404976 0393055 0402979 0358989 0365946 0399776 0404124 0408612 0358989 0360992 0360992 0402979 0360992 0402979 0392886 0353140 0360992 0393055 0360992 0392202 0355828 0377903 0355828 0393055 0393439 0409335 0393439 0351750 0353140 0355822 0355821 0355822 0355828 0392202 0355903 0355821 0355821 0366633 0392219 0392219 0392219 0366633 Class II Lack of Assurance of Sterility: Franck's Lab Inc. initiated a recall of all Sterile Human Drugs distributed between 11/21/2011 and 05/21/2012 because FDA environmental sampling revealed the presence of microorganisms and fungal growth in the clean room where sterile products were prepared. Franck's Lab Inc., d.b.a. Franck's Compounding Lab
Drugs BIEST(80/20) 6.25MG/GM (1.25MG/0.2ML) I-CREAM 6 ML (5 DIFFERENT PRODUCTS) Rx #: 0392274 Class II Lack of Assurance of Sterility: Franck's Lab Inc. initiated a recall of all Sterile Human Drugs distributed between 11/21/2011 and 05/21/2012 because FDA environmental sampling revealed the presence of microorganisms and fungal growth in the clean room where sterile products were prepared. Franck's Lab Inc., d.b.a. Franck's Compounding Lab
Drugs BIMIX 30MG / 4MG INJECTABLE 10 ML, 5 ML; BIMIX 30MG / 5MG INJECTABLE 10 ML; BIMIX 9MG / 0.25MG INJECTABLE 10 ML, 5 ML; BIMIX 15MG / 1MG INJECTABLE 10 ML; BIMIX 18MG / 0.5MG INJECTABLE 10 ML, 5 ML; BIMIX 18MG / 1MG INJECTABLE 5 ML; BIMIX 20MG / 0.75MG INJECTABLE 5 ML; BIMIX 26MG/1MG/ML INJECTABLE 10 ML; BIMIX 26MG/2MG/ML INJECTABLE 20 ML; BIMIX 30MG / 0.5MG INJECTABLE 10 ML, 20 ML,5 ML, 50 ML, 60 ML; BIMIX 30MG / 1.5MG INJECTABLE 5 ML; BIMIX 30MG/1MG INJECTABLE 1 ML, 10 ML, 10 MLS, 12 ML, 150 ML, 2 ML, 20 ML, 20 MLS, 3 ML, 30 ML, 40 ML, 5 ML, 5 MLS, 50 ML, 6 ML, 60 ML, 7 ML; BIMIX 9MG / 0.5MG/ML INJECTABLE 5 ML; BIMIX 15MG / 0.5MG INJECTABLE 10 ML, 5 ML; BIMIX 16.6MG / 0.55MG/ML INJECTABLE 10 ML, 4.5 ML; BIMIX 30MG / 2MG INJECTABLE 10 ML, 5 ML; BIMIX 30MG/3MG/ML INJECTABLE 10 ML, 5 ML; BIMIX 40MG/2MG INJECTABLE 10 ML, 3 ML, 6 ML; BIMIX 40MG/3MG INJECTABLE 3 ML; BIMIX, SDSM 9MG / 0.25MG INJECTABLE 10 ML; BIMIX, SDSM 9MG / 0.5MG INJECTABLE 10 ML; BIMIX, SDSM 18MG / 0.5MG INJECTABLE 10 ML, 10 MLS; BIMIX, SDSM 30MG / 1.5MG INJECTABLE 10 ML, 10 MLS, 5 ML, 5 MLS; BIMIX, SDSM 30MG / 1MG INJECTABLE 10 ML, 5 ML (58 DIFFERENT PRODUCTS) Rx #'s: 0384355, 0389246, 0392332, 0399800, 0407377, 0385460, 0389158, 0402762, 0385460, 0359057, 0385462, 0396242, 0385462, 0391321, 0372399, 0400437, 388360, 0350745, 0354900, 0357950, 0365803, 0391686, 0393285, 0393620, 0395404, 0399228, 0399302, 0401675, 0401844, 0403731, 0406162, 0408427, 0409073, 0399228, 0371562, 0376422, 0396380, 0405576, 0405582, 0405586, 0384289, 0366702, 0360431, 0408278, 0390548, 0396007, 0401479, 0352078, 0352368, 0354526, 0354595, 0357480, 0358685, 0359207, 0363768, 0364549, 0368498, 0369212 0373766 0374428 0375279 0375571 0375873 0377397 0380000 0380005 0381659 0382914 0384657 0386665 0387419 0387519 0387699 0388026 0388292 0388330 0388766 0389900 0390082 0390315 0391607 0392449 0392525 0392848 0393087 0393381 0393499 0393828 0393904 0394395 0394985 0395878 0395912 0396010 0396019 0396120 0396163 0396207 0396267 0396366 0396906 0397063 0397523 0397527 0397728 0398291 0398862 0399237 0399251 0399644 0399898 0401001 0401380 0401414 0401480 0401858 0401991 0402382 0402634 0403182 0403417 0404396 0404958 0404962 0404965 0405377 0405697 0406246 0406753 0406809 0407466 0407512 0407521 0407830 0408706 0408768 0408828 0409007 0409150 0409158 0409809 0388728 0409113 0395179 0401812 0380005 0390728 0408848 0357188 0380005 0388326 0388531 0398590 0407315 0359319 0379979 0380005 0398376 0406549 0390081 0390728 0406512 0350594 0351237 0354526 0358579 0358794 0361059 0362431 0363752 0367108 0367355 0368710 0369213 0369806 0369811 0370264 0370618 0373793 0375571 0378322 0378326 0378513 0378942 0379218 0379983 0380003 0380005 0380149 0382749 0383556 0386269 0386665 0387095 0387179 0387861 0388633 0388634 0388636 0388637 0388638 0388641 0388894 0389374 0389385 0389548 0389790 0390777 0390779 0390781 0390782 0390784 0390790 0392100 0392378 0392380 0392388 0392390 0392508 0392649 0393106 0393111 0393112 0393114 0393115 0393117 0393118 0393836 0393838 0393839 0393841 0393843 0393846 0393848 0394141 0394181 0395615 0395620 0395622 0395623 0395625 0395628 0395632 0395635 0395636 0395921 0396045 0396534 0397327 0397406 0397473 0397475 0397476 0398304 0398372 0399460 0399467 0399469 0399471 0399476 0399478 0399481 0399841 0400028 0400032 0400169 0400782 0400791 0401362 0401477 0402466 0402681 0402687 0402699 0402709 0402711 0402713 0402715 0403292 0403743 0404300 0404953 0405053 0405058 0405061 0405264 0405284 0405391 0405392 0405394 0405850 0405855 0405863 0405866 0406896 0407031 0407430 0407614 0407619 0407623 0407625 0407626 0407631 0407708 0407758 0407835 0407845 0408266 0408719 0408839 0409260 0409369 0409644 0409663 0409666 0409667 0409672 0409676 0409685 0409803 0409810 0409811 0409984 0410385 0376121 0388330 0398376 0402184 0354526 0380005 0384306 0402150 0380005 0395412 0351617 0377040 0405279 0351625 0398027 0400613 0405073 0356174 0366355 0366652 0372365 0377239 0377604 0384197 0384239 0388883 0389914 0390003 0392798 0393394 0393804 0396191 0396863 0398155 0400682 0401354 0402361 0402772 0406281 0407525 0408139 0408807 0366728 0395638 0392966 0402974 0405261 0397156 0390549 0405381 0359548 0381259 0390539 0396023 0405381 0359548 0405381 0388337 0391331 0395269 0408053 0392770 0360349 0382004 0394651 0404245 0406333 0397786 0394838 0389554 0395413 0397465 0395413 0395411 0395411 Class II Lack of Assurance of Sterility: Franck's Lab Inc. initiated a recall of all Sterile Human Drugs distributed between 11/21/2011 and 05/21/2012 because FDA environmental sampling revealed the presence of microorganisms and fungal growth in the clean room where sterile products were prepared. Franck's Lab Inc., d.b.a. Franck's Compounding Lab
Drugs BORON 2MG/ML INJECTABLE 40 ML (2 DIFFERENT PRODUCTS) Rx #'s: 0383013, 0383013 Class II Lack of Assurance of Sterility: Franck's Lab Inc. initiated a recall of all Sterile Human Drugs distributed between 11/21/2011 and 05/21/2012 because FDA environmental sampling revealed the presence of microorganisms and fungal growth in the clean room where sterile products were prepared. Franck's Lab Inc., d.b.a. Franck's Compounding Lab
Drugs BRILLIANT BLUE G, P.F. 0.025% OPHTHALMIC 10 ML, 20 ML, 26 ML, 4 ML; BRILLIANT BLUE G, P.F. (0.5ML SYRINGE) 0.25MG/ML OPHTHALMIC 2 ML, 2.5 ML, 5 ML; BRILLIANT BLUE G, P.F. (0.5ML SYRINGE) 0.5MG/ML OPHTHALMIC 1.5 ML; BRILLIANT BLUE G, P.F. (0.5ML SYRINGE) 1% OPHTHALMIC 0.5 ML,1 ML,1.5 ML, 2 ML, 3 ML, 5 ML, 6 ML, 8 ML; BRILLIANT BLUE G, P.F. (STSL) (0.5ML SYRINGE) 0.025% OPHTHALMIC 2.5 ML, 5 ML; BRILLIANT BLUE G, P.F. (STSL) (0.5ML SYRINGE) 0.15% OPHTHALMIC 2.5 ML; BRILLIANT BLUE G, P.F. 0.25% OPHTHALMIC 1 ML, 10 ML, 20 ML; BRILLIANT BLUE G, P.F. 0.5% OPHTHALMIC 1 ML, 10 ML, 20 ML, 5 ML; BRILLIANT BLUE G, P.F. 1% OPHTHALMIC 10 ML, 12 ML, 15 ML, 2 ML, 2 MLS, 20 ., 20 ML, 30 ML, 4 ML, 40 ML, 50 ML, 6 ML, 80 ML, 9 ML; BRILLIANT BLUE G, P.F. 2% OPHTHALMIC 11 MLS, 15 MLS (43 DIFFERENT PRODUCTS) Rx #'s: 0387683 0393065 0394633 0385938 0387683 0385222 0394375 0389789 0394526 0391261 0399698 0380189 0387389 0384308 0387389 0390830 0370011 0386507 0394133 0397580 0386507 0393521 0374071 0396478 0360399 0377887 0382420 0360399 0382420 0373839 0373839 0367517 0395929 0396303 0398978 0398980 0398983 0398987 0398061 0395908 0366449 0366449 0385953 0395908 0368413 0386587 0387945 0388529 0388631 0390720 0392250 0393056 0395446 0397146 0397459 0399806 0354531 0397967 0399668 0387481 0394553 0396177 0398687 0395424 0388631 0369860 0381370 0388529 0388631 0390143 0392319 0392455 0381370 0393958 0393960 0395294 0396324 0397146 0397149 0389458 0390143 0357319 0369209 0389845 0396123 0360125 0366749 0366749 Class II Lack of Assurance of Sterility: Franck's Lab Inc. initiated a recall of all Sterile Human Drugs distributed between 11/21/2011 and 05/21/2012 because FDA environmental sampling revealed the presence of microorganisms and fungal growth in the clean room where sterile products were prepared. Franck's Lab Inc., d.b.a. Franck's Compounding Lab
Drugs BUDESONIDE (P.F) NASAL IRRIGATION 0.5MG/500ML SOLUTION 1000 ML; BUDESONIDE (P.F) NASAL IRRIGATION 0.6MG/50ML SOLUTION 1500 ML (2 DIFFERENT UNITS) Rx #'s: 0390774, 0392517 Class II Lack of Assurance of Sterility: Franck's Lab Inc. initiated a recall of all Sterile Human Drugs distributed between 11/21/2011 and 05/21/2012 because FDA environmental sampling revealed the presence of microorganisms and fungal growth in the clean room where sterile products were prepared. Franck's Lab Inc., d.b.a. Franck's Compounding Lab
Drugs BUPIVACAINE HCL & EPINEPHRINE, P.F. 0.25% / 1:200,000 INJECTABLE 900 ML; BUPIVACAINE HCL & EPINEPHRINE, P.F. 0.5% / 1:200,000 INJECTABLE 900 ML; BUPIVACAINE HCL 0.25% INJECTABLE 120 ML,180 ML, 240 ML, 250 ML, 300 ML, 500 ML, 60 ML; BUPIVACAINE HCL 0.5% INJECTABLE1000 ML, 120 ML, 200 ML, 250 ML, 400 ML, 50 ML, 500 ML, 600 ML, 750 ML; BUPIVACAINE HCL, P.F. 0.25% INJECTABLE 1000 ML, 120 ML, 1200 ML, 150 ML, 1500 ML, 180 ML, 240 ML, 300 ML, 60 ML, 600 ML, 900 ML; BUPIVACAINE HCL, P.F. 0.5% INJECTABLE 10 ML, 120 ML, 1500 ML, 20 ML, 200 ML, 240 ML, 2500 ML, 300 ML, 360 ML, 600 ML, 960 ML; BUPIVACAINE HCL, P.F. 0.75% INJECTABLE 1200 ML, 150 ML, 240 ML, 30 ML, 600 ML, 7 ML (47 DIFFERENT PRODUCTS) Rx #'s: 0402964 0402963 0398083 0398557 0398524 0406883 0396497 0401829 0407441 0408458 0408393 0398196 0398084 0405518 0397074 0401694 0401412 0398196 0404325 0397888 0407444 0408529 0408099 0401897 0402614 0405996 0402614 0405382 0398014 0398022 0400197 0400116 0400197 0401897 0405996 0398014 0402614 0398014 0401755 0401755 0404391 0402616 0401688 0398026 0399744 0402617 0398026 0401755 0398026 0402616 0400850 0404643 0408996 0403960 0400509 0400960 0403759 0404643 0405771 Class II Lack of Assurance of Sterility: Franck's Lab Inc. initiated a recall of all Sterile Human Drugs distributed between 11/21/2011 and 05/21/2012 because FDA environmental sampling revealed the presence of microorganisms and fungal growth in the clean room where sterile products were prepared. Franck's Lab Inc., d.b.a. Franck's Compounding Lab
Drugs BUPIVACAINE/CLONIDINE/HYDROMORPHONE, P.F. 20MG/400MCG/2MG/ML INTRATHECAL; BUPIVACAINE/CLONIDINE/HYDROMORPHONE, P.F. 7.5MG/1.5MCG/50MG/ML INTRATHECAL; BUPIVACAINE/CLONIDINE/HYDROMORPHONE, P.F. 5MG/500MCG/50MG/ML INTRATHECAL (4 DIFFERENT PRODUCTS) Rx #'s:N0388659 N0392060 N0406634 N0406913 N0397272 Class II Lack of Assurance of Sterility: Franck's Lab Inc. initiated a recall of all Sterile Human Drugs distributed between 11/21/2011 and 05/21/2012 because FDA environmental sampling revealed the presence of microorganisms and fungal growth in the clean room where sterile products were prepared. Franck's Lab Inc., d.b.a. Franck's Compounding Lab
Drugs BUPIVACAINE/CLONIDINE/MORPHINE, P.F. 20MG/400MCG/20MG/ML INTRATHECAL 20 ML (1 PRODUCT) Rx #'s:N0397554 N0402371 Class II Lack of Assurance of Sterility: Franck's Lab Inc. initiated a recall of all Sterile Human Drugs distributed between 11/21/2011 and 05/21/2012 because FDA environmental sampling revealed the presence of microorganisms and fungal growth in the clean room where sterile products were prepared. Franck's Lab Inc., d.b.a. Franck's Compounding Lab
Drugs BUPIVACAINE/CLONIDINE/MORPHINE/ZICONOTIDE, P.F. 20MG/400MCG/20MG/1.5MCG/ML INTRA 20 ML (1 PRODUCT) Rx #:N0408712 Class II Lack of Assurance of Sterility: Franck's Lab Inc. initiated a recall of all Sterile Human Drugs distributed between 11/21/2011 and 05/21/2012 because FDA environmental sampling revealed the presence of microorganisms and fungal growth in the clean room where sterile products were prepared. Franck's Lab Inc., d.b.a. Franck's Compounding Lab
Drugs BUPIVACAINE/FENTANYL IN SODIUM CHLORIDE 0.9% P. F. 30 MG/200 MCG/ML INTRATHECAL 40 ML (1 PRODUCT) Rx #'s:N0391834 N0401851 Class II Lack of Assurance of Sterility: Franck's Lab Inc. initiated a recall of all Sterile Human Drugs distributed between 11/21/2011 and 05/21/2012 because FDA environmental sampling revealed the presence of microorganisms and fungal growth in the clean room where sterile products were prepared. Franck's Lab Inc., d.b.a. Franck's Compounding Lab
Drugs BUPIVACAINE/HYDROMORPHONE, P.F. 15MG/40MG/ML INTRATHECAL 40 ML; BUPIVACAINE/HYDROMORPHONE, P.F. 22MG/30MG/ML INTRATHECAL 40 ML; BUPIVACAINE/HYDROMORPHONE, P.F. 7.5MG/20MG/ML INTRATHECAL 40 ML; BUPIVACAINE/HYDROMORPHONE, P.F. 7.5MG/25MG/ML INTRATHECAL 18 ML; BUPIVACAINE/HYDROMORPHONE, P.F. 7.5MG/50MG/ML INTRATHECAL 18 ML, 40 ML (6 DIFFERENT PRODUCTS) Rx #'s:N0408787 N0390587 N0391850 N0397485 N0403240 N0387609 N0393487 N0393643 N0403803 N0388585 N0393489 N0401153 N0387605 N0405433 N0408195 Class II Lack of Assurance of Sterility: Franck's Lab Inc. initiated a recall of all Sterile Human Drugs distributed between 11/21/2011 and 05/21/2012 because FDA environmental sampling revealed the presence of microorganisms and fungal growth in the clean room where sterile products were prepared. Franck's Lab Inc., d.b.a. Franck's Compounding Lab
Drugs BUPIVACAINE/LIDOCAINE 0.11% / 0.44% INJECTABLE 150 ML (1 PRODUCT) Rx #: 0386455 Class II Lack of Assurance of Sterility: Franck's Lab Inc. initiated a recall of all Sterile Human Drugs distributed between 11/21/2011 and 05/21/2012 because FDA environmental sampling revealed the presence of microorganisms and fungal growth in the clean room where sterile products were prepared. Franck's Lab Inc., d.b.a. Franck's Compounding Lab
Drugs BUPIVACAINE/LIDOCAINE/METHYLPREDNISOLONE 0.17% / 0.67% / 2.7% INJECTABLE 15 ML, 18.75 ML, 26.25 ML, 37.5 ML, 45 ML; BUPIVACAINE/LIDOCAINE/METHYLPREDNISOLONE 0.22% / 0.88% / 0.88% INJECTABLE 450 ML, 900 ML (7 DIFFERENT PRODUCTS) Rx #'s: 0383652 0383653 0383653 0383652 0383652 0383651 0383651 Class II Lack of Assurance of Sterility: Franck's Lab Inc. initiated a recall of all Sterile Human Drugs distributed between 11/21/2011 and 05/21/2012 because FDA environmental sampling revealed the presence of microorganisms and fungal growth in the clean room where sterile products were prepared. Franck's Lab Inc., d.b.a. Franck's Compounding Lab
Drugs BUPIVACAINE/MORPHINE SULFATE, P.F. 2.5MG/10MG/ML INTRATHECAL 40 ML; BUPIVACAINE/MORPHINE SULFATE, P.F. 7.5MG/25MG/ML INTRATHECAL 20 ML; BUPIVACAINE/MORPHINE SULFATE, P.F. 7.5MG/50MG/ML INTRATHECAL 18 ML, 35 ML (4 DIFFERENT PRODUCTS) Rx #'s:N0396140 N0408047 N0390990 N0400772 N0387610 N0391586 N0393141 N0396643 N0398235 N0402376 N0404186 N0409166 N0410206 N0387612 N0394426 N0402375 Class II Lack of Assurance of Sterility: Franck's Lab Inc. initiated a recall of all Sterile Human Drugs distributed between 11/21/2011 and 05/21/2012 because FDA environmental sampling revealed the presence of microorganisms and fungal growth in the clean room where sterile products were prepared. Franck's Lab Inc., d.b.a. Franck's Compounding Lab
Drugs BUPIVACAINE/SUFENTANIL, P.F. 15MG/150MCG/ML INTRATHECAL 20 ML (1 PRODUCT) Rx #:N0390025 N0399831 Class II Lack of Assurance of Sterility: Franck's Lab Inc. initiated a recall of all Sterile Human Drugs distributed between 11/21/2011 and 05/21/2012 because FDA environmental sampling revealed the presence of microorganisms and fungal growth in the clean room where sterile products were prepared. Franck's Lab Inc., d.b.a. Franck's Compounding Lab
Drugs CALCIUM CHLORIDE DIHYDRATE, P.F. 100MG/ML (10%) INJECTABLE 200 ML, 240 ML, 500 ML; CALCIUM EDTA 150MG/ML INJECTABLE 1000 ML, 800 ML, 900 ML; CALCIUM EDTA 300MG/ML INJECTABLE 400 ML, 500 ML; CALCIUM GLUCONATE OPHTHALMIC IN ARTIFICIAL TEARS 1% OPHTHALMIC 500 ML (9 DIFFERENT PRODUCTS) Rx #'s: 0392865 0396841 0392865 0389079 0401264 0401264 0389079 0351538 0379811 0398960 0396622 0367514 Class II Lack of Assurance of Sterility: Franck's Lab Inc. initiated a recall of all Sterile Human Drugs distributed between 11/21/2011 and 05/21/2012 because FDA environmental sampling revealed the presence of microorganisms and fungal growth in the clean room where sterile products were prepared. Franck's Lab Inc., d.b.a. Franck's Compounding Lab
Drugs CEFAZOLIN IN ARTIFICIAL TEARS 50MG/ML OPHTHALMIC 10 ML; CEFAZOLIN VIAL*(25X1GM) 1GM INJECTABLE 10 VIAL (2 DIFFERENT PRODUCTS) Rx #'s: 0408353 0404128 Class II Lack of Assurance of Sterility: Franck's Lab Inc. initiated a recall of all Sterile Human Drugs distributed between 11/21/2011 and 05/21/2012 because FDA environmental sampling revealed the presence of microorganisms and fungal growth in the clean room where sterile products were prepared. Franck's Lab Inc., d.b.a. Franck's Compounding Lab
Drugs CEFTAZIDIME OPHTHALMIC, P.F. 22.5MG/ML (2.25%) OPHTHALMIC 1 ML, 2ML, 2 MLS, 6 ML CEFTAZIDIME, LYOPHILIZED, OPHTHALMIC KIT 2.25% KIT 1 KIT 12 KIT 16 KIT 2 KIT 2 KITS 20 KIT 3 KIT 3 KITS 4 KIT 4 KITS 4 VIALS 5 KIT 6 KIT 6 VIAL 8 KIT CEFTAZIDIME, SDPF - (0.2ML SYRINGE, 30G, 1/2") 2.25% INJECTABLE 0.2 ML 0.4 ML 0.6 ML 0.8 ML 1.2 ML 1.6 ML (25 DIFFERENT PRODUCTS) Rx #'s: 0400830 0400830 0403915 0369559 0382655 0355231 0363469 0364194 0364586 0365232 0368229 0368502 0368575 0379338 0379547 0383465 0387854 0389349 0390953 0391076 0392073 0394447 0394682 0394934 0395429 0395951 0396729 0397109 0397667 0404203 0404799 0405703 0406025 0408991 0359179 0359179 0348862 0356877 0360153 0363384 0363885 0364194 0364239 0366032 0366271 0368245 0368882 0376169 0380550 0382237 0384296 0385288 0387375 0387380 0387486 0388896 0389392 0390771 0392073 0394447 0399970 0399989 0403141 0403755 0405329 0365743 0384729 0389303 0396299 0353130 0355933 0356625 0362693 0363384 0363667 0368575 0368882 0371797 0375692 0380344 0383379 0387330 0387486 0388896 0392336 0392543 0395951 0396870 0402552 0409017 0375411 0395390 0358612 0362693 0366271 0371046 0375511 0375514 0375515 0375518 0375519 0375692 0384296 0387483 0392020 0392336 0408625 0376091 0399724 0356877 0405109 0408823 0362693 0371046 0375356 0375503 0375504 0375506 0375507 0375510 0375511 0375514 0375515 0375518 0375519 0392020 0392336 0396870 0398875 0368836 0354413 0398562 0354048 0389058 0389206 0405941 0358048 0387432 0402040 0391715 0391715 0393524 0404316 0391708 0402008 0391708 Class II Lack of Assurance of Sterility: Franck's Lab Inc. initiated a recall of all Sterile Human Drugs distributed between 11/21/2011 and 05/21/2012 because FDA environmental sampling revealed the presence of microorganisms and fungal growth in the clean room where sterile products were prepared. Franck's Lab Inc., d.b.a. Franck's Compounding Lab
Drugs CHORIONIC GONADOTROPIN (STANDARD) - 21 DAY 200 UNIT VIALS KIT 1 KIT; CHORIONIC GONADOTROPIN (STANDARD) - 45 DAY 200 UNIT VIALS KIT 1 KIT; CHORIONIC GONADOTROPIN (STANDARD)-21 DAY 125 UNIT VIALS KIT 1 KIT; CHORIONIC GONADOTROPIN (STANDARD)-45 DAY 125 UNIT VIALS KIT 1 KIT; CHORIONIC GONADOTROPIN + B12, LYOPHILIZED 4,000 UNIT/40MCG/ML KIT 1 KIT, 2 KIT, 3 KIT; CHORIONIC GONADOTROPIN + B12, LYOPHILIZED (HCG) 4,000 UNIT VIAL INJECTABLE 1 VIAL, 12 VIALS; CHORIONIC GONADOTROPIN KIT 5,000 UNIT VIAL INJECTABLE 1 KIT; CHORIONIC GONADOTROPIN** KIT 10,000 UNIT VIAL INJECTABLE 1 KIT; CHORIONIC GONADOTROPIN, HUMAN - MINI 250 UNITS TROCHE 30 TROCHE, 45 TROCHE, 50 TROCHE, 60 TROCHE, 80 TROCHE; CHORIONIC GONADOTROPIN, LYOPHILIZED (HCG) 1,000 UNIT VIAL INJECTABLE 30 VIAL; CHORIONIC GONADOTROPIN, LYOPHILIZED (HCG) 5,000 UNIT VIAL INJECTABLE 1 VIAL, 10 VIAL, 14 VIAL, 15 VIAL, 2 VIAL, 2 VIALS, 20 VIAL, 3 VIAL, 5 VIAL, 6 VIAL; CHORIONIC GONADOTROPIN, LYOPHILIZED (HCG) 125 UNIT VIAL (UNIT DOSE) INJECTABLE 10 VIAL, 14 VIAL, 15 VIAL, 2 VIAL, 24 VIAL, 28 VIAL, 28 VIALS, 7 VIAL, 7 VIALS; CHORIONIC GONADOTROPIN, LYOPHILIZED (HCG) 2,500 UNIT VIAL INJECTABLE 5 VIAL; CHORIONIC GONADOTROPIN, LYOPHILIZED (HCG) 200 UNIT VIAL (UNIT DOSE) INJECTABLE 22 VIAL, 25 VIAL, 8 VIAL (40 DIFFERENT PRODUCTS) Rx #'s: 0389332 0388230 0362007 0362537 0369266 0369759 0376765 0376766 0378972 0381347 0381668 0383006 0384070 0387408 0387842 0387873 0388522 0388825 0389034 0389038 0389347 0389746 0389824 0389913 0390210 0390265 0390267 0390404 0390481 0391083 0391374 0391789 0392302 0392329 0393161 0393238 0393733 0393734 0394038 0396204 0396253 0396951 0397068 0397814 0397816 0398167 0398775 0398809 0399039 0399168 0400419 0401454 0401456 0401717 0402440 0402443 0403637 0377693 0382907 0389892 0390269 0393418 0397085 0397984 0398761 0401192 0401453 0401702 0402969 0403042 0353856 0380968 0389852 0396383 0396985 0397369 0405720 0409461 0400111 0392017 0405577 0405591 0407190 0390553 0410265 0393727 0394656 0399169 0403590 0392209 0392212 0392214 0392215 0392217 0394902 0395795 0395799 0395800 0395880 0395884 0395885 0398821 0399797 0403933 0405574 0405578 0405607 0405608 0406394 0410495 0394528 0395347 0392045 0393681 0393682 0394381 0396742 0396763 0401783 0401785 0405205 0404805 0397298 0398209 0401610 0404696 0406424 0408386 0408794 0409008 0409330 0409500 0409511 0410093 0410179 0410202 0410327 0394569 0397231 0400352 0400360 0410043 0410045 0410046 0394569 0394569 0407106 0407854 0409176 0408788 0394569 0405634 0394765 0405634 0392318 0394569 0373437 0381856 0387413 0397985 0398350 0394512 0401471 0404558 0393614 0397800 0387413 0406999 0397800 0397822 0388830 0380110 0407385 0380110 Class II Lack of Assurance of Sterility: Franck's Lab Inc. initiated a recall of all Sterile Human Drugs distributed between 11/21/2011 and 05/21/2012 because FDA environmental sampling revealed the presence of microorganisms and fungal growth in the clean room where sterile products were prepared. Franck's Lab Inc., d.b.a. Franck's Compounding Lab
Drugs CHROMIUM PICOLINATE 200MCG/ML INJECTABLE 60 ML (1 PRODUCT) Rx #'s: 0353549 0398279 Class II Lack of Assurance of Sterility: Franck's Lab Inc. initiated a recall of all Sterile Human Drugs distributed between 11/21/2011 and 05/21/2012 because FDA environmental sampling revealed the presence of microorganisms and fungal growth in the clean room where sterile products were prepared. Franck's Lab Inc., d.b.a. Franck's Compounding Lab
Drugs CISPLATIN 1MG/ML INJECTABLE 1000 ML, 2000 ML (2 DIFFERENT PRODUCTS) Rx #"s: 0392538 0391562 0391564 Class II Lack of Assurance of Sterility: Franck's Lab Inc. initiated a recall of all Sterile Human Drugs distributed between 11/21/2011 and 05/21/2012 because FDA environmental sampling revealed the presence of microorganisms and fungal growth in the clean room where sterile products were prepared. Franck's Lab Inc., d.b.a. Franck's Compounding Lab
Drugs CLINDAMYCIN OPHTHALMIC (PF) 20MG/ML (2MG/0.1ML) SOLUTION 2 ML; CLINDAMYCIN PHOSPHATE OPHTHALMIC, INTRAVITREAL (P.F.) 1MG/0.1ML INJECTABLE 0.2 ML; CLINDAMYCIN PHOSPHATE SDPF- (0.1ML SYRINGE,30G,1/2") 1MG/0.1ML INJECTABLE 0.1 ML (3 DIFFERENT PRODUCTS) Rx #'s: 0397741 0402847 0396295 0394438 Class II Lack of Assurance of Sterility: Franck's Lab Inc. initiated a recall of all Sterile Human Drugs distributed between 11/21/2011 and 05/21/2012 because FDA environmental sampling revealed the presence of microorganisms and fungal growth in the clean room where sterile products were prepared. Franck's Lab Inc., d.b.a. Franck's Compounding Lab
Drugs COPPER GLUCONATE 2MG/ML INJECTABLE 30 ML, 60 ML (2 DIFFERENT PRODUCTS) Rx #'s: 0398939 0389889 0398939 Class II Lack of Assurance of Sterility: Franck's Lab Inc. initiated a recall of all Sterile Human Drugs distributed between 11/21/2011 and 05/21/2012 because FDA environmental sampling revealed the presence of microorganisms and fungal growth in the clean room where sterile products were prepared. Franck's Lab Inc., d.b.a. Franck's Compounding Lab
Drugs CYANOCOBALAMIN (VIT B12 ) 1,000MCG/ML INJECTABLE 1 ML, 10 ML, 100 ML, 12 ML, 120 ML, 15 ML, 150 ML, 180 ML, 2 ML, 200 ML, 3 ML, 30 ML, 300 ML, 32 ML, 4 ML, 5 ML, 6 ML, 60 ML, 90 ML; CYANOCOBALAMIN **1000MCG/ML INJECTABLE 1000MCG/ML INJECTABLE 30 ML; CYANOCOBALAMIN*** (25X10ML VIAL) 1000MCG/ML INJECTABLE 10 ML, 20 MLS, 40 ML; CYANOCOBALMIN ***(VIT B-12) 25X1ML 1000MCG/ML INJECTABLE 50 MLS (24 DIFFERENT PRODUCTS) Rx #'s: 0387434 0387442 0373259 0379220 0379925 0381812 0382155 0389481 0391043 0391912 0392598 0393303 0397302 0368903 0385563 0377621 0389560 0376591 0387169 0375580 0388039 0381499 0387434 0387442 0368903 0398369 0385601 0381154 0382450 0395591 0399380 0400168 0401501 0375406 0388039 0370251 0379203 0380414 0373568 0373668 0379036 0376722 0380943 0381499 0384292 0388741 0395917 0373742 0387702 0389521 0373742 0401945 0409583 0404840 0407920 0407921 0407922 0407923 0407925 0407926 0407928 0407931 0407933 0407935 0403019 0406664 Class II Lack of Assurance of Sterility: Franck's Lab Inc. initiated a recall of all Sterile Human Drugs distributed between 11/21/2011 and 05/21/2012 because FDA environmental sampling revealed the presence of microorganisms and fungal growth in the clean room where sterile products were prepared. Franck's Lab Inc., d.b.a. Franck's Compounding Lab
Drugs CYCLOPENT/FLURBIPR/PHENYLEPH/PROPARACAINE .25%/0.0075%/0.625%/0.125% OPHTHALMIC 56 ML, 70 ML (2 DIFFERENT PRODUCTS) Rx #'s: 0368702 0368702 Class II Lack of Assurance of Sterility: Franck's Lab Inc. initiated a recall of all Sterile Human Drugs distributed between 11/21/2011 and 05/21/2012 because FDA environmental sampling revealed the presence of microorganisms and fungal growth in the clean room where sterile products were prepared. Franck's Lab Inc., d.b.a. Franck's Compounding Lab
Drugs CYCLOPENT/KETOROLAC/PHENYLEPH/TROPICAMIDE 1%/0.5%/2.5%/1% OPHTHALMIC 70 ML (1 PRODUCT) Rx #'s: 0358393 0400281 Class II Lack of Assurance of Sterility: Franck's Lab Inc. initiated a recall of all Sterile Human Drugs distributed between 11/21/2011 and 05/21/2012 because FDA environmental sampling revealed the presence of microorganisms and fungal growth in the clean room where sterile products were prepared. Franck's Lab Inc., d.b.a. Franck's Compounding Lab
Drugs CYCLOPENT/LIDOCAINE/PHENYLEPHRINE/TROPICAMIDE 0.5%/0.5%/0.625%/0.25% OPHTHALMIC 20 ML (1 PRODUCT) Rx #: 0392313 Class II Lack of Assurance of Sterility: Franck's Lab Inc. initiated a recall of all Sterile Human Drugs distributed between 11/21/2011 and 05/21/2012 because FDA environmental sampling revealed the presence of microorganisms and fungal growth in the clean room where sterile products were prepared. Franck's Lab Inc., d.b.a. Franck's Compounding Lab
Drugs CYCLOPENT/PHENYLEPH/TROPICAMIDE/PROPARACAINE 2%/2.5%/1%/0.5% OPHTHALMIC 5 ML (1 PRODUCT) Rx #: 0387447 Class II Lack of Assurance of Sterility: Franck's Lab Inc. initiated a recall of all Sterile Human Drugs distributed between 11/21/2011 and 05/21/2012 because FDA environmental sampling revealed the presence of microorganisms and fungal growth in the clean room where sterile products were prepared. Franck's Lab Inc., d.b.a. Franck's Compounding Lab
Drugs CYCLOPENTALATE/PHENYLEPHRINE 1%/2.5% OPHTHALMIC 5 ML (1 PRODUCT) Rx #: 0387441 Class II Lack of Assurance of Sterility: Franck's Lab Inc. initiated a recall of all Sterile Human Drugs distributed between 11/21/2011 and 05/21/2012 because FDA environmental sampling revealed the presence of microorganisms and fungal growth in the clean room where sterile products were prepared. Franck's Lab Inc., d.b.a. Franck's Compounding Lab
Drugs CYCLOSPORINE (A) AQUEOUS (HUMAN) 0.5% OPHTHALMIC 10 ML, 5 ML; CYCLOSPORINE (A) AQUEOUS PF (HUMAN) 0.2% OPHTHALMIC 10 ML; CYCLOSPORINE (A) AQUEOUS PF (HUMAN) 1% OPHTHALMIC 10 ML; CYCLOSPORINE (A) CORN OIL SOLUTION 2% OPHTHALMIC 15 ML; CYCLOSPORINE (A) OIL SOLUTION 1% OPHTHALMIC 10 ML, 20 ML, 60 ML; CYCLOSPORINE (A) OIL SOLUTION 2% OPHTHALMIC 10 ML, 15 ML, 20 ML, 30 ML (12 DIFFERENT PRODUCTS) Rx #'s: 0398633 0374138 0407059 0395611 0366358 0382466 0385492 0405984 0407947 0409833 0369221 0401142 0364989 0385219 0389327 0389381 0395535 0402826 0406693 Class II Lack of Assurance of Sterility: Franck's Lab Inc. initiated a recall of all Sterile Human Drugs distributed between 11/21/2011 and 05/21/2012 because FDA environmental sampling revealed the presence of microorganisms and fungal growth in the clean room where sterile products were prepared. Franck's Lab Inc., d.b.a. Franck's Compounding Lab
Drugs DAPIPRAZOLE OPHTHALMIC 0.5% SOLUTION 10 ML; DAPIPRAZOLE, LYOPHILIZED, OPHTHALMIC KIT 0.5% POWDER 1 KIT, 10 KIT, 2 KIT, 3 KIT, 4 KIT, 6 KIT (7 DIFFERENT PRODUCTS) Rx #'s: 0402838 0366311 0393844 0405862 0369802 0361586 0362348 0367636 0354323 0361586 0376846 0395405 0401667 0404458 0356814 0372189 Class II Lack of Assurance of Sterility: Franck's Lab Inc. initiated a recall of all Sterile Human Drugs distributed between 11/21/2011 and 05/21/2012 because FDA environmental sampling revealed the presence of microorganisms and fungal growth in the clean room where sterile products were prepared. Franck's Lab Inc., d.b.a. Franck's Compounding Lab
Drugs DEXAMETHASONE SODIUM PHOSPHATE PF 0.04% OPHTHALMIC 2 ML; DEXAMETHASONE / LIDOCAINE 0.5%/3% INJECTABLE 30 MLS; DEXAMETHASONE ACETATE (LA) 8MG/ML INJECTABLE 100 ML; DEXAMETHASONE IONTOPHORESIS, STERILE, P.F. 4MG/ML SOLUTION 20 ML, 30 ML (35 DIFFERENT PRODUCTS) 40 ML DEXAMETHASONE SDPF (0.1ML SYRINGE, 31G, 5/16" ) 0.4MG/ML INJECTABLE 0.3 ML 0.5 ML DEXAMETHASONE SODIUM PHOSPHATE (P.F.) 10MG/ML (1%) INJECTABLE 0.05 ML 1 ML 16 ML 2 ML 24 ML 3 ML 32 ML 8 ML DEXAMETHASONE SODIUM PHOSPHATE (P.F.) 4MG/ML (0.4%) INJECTABLE 0.4 ML 2 ML 3 ML 5 ML 6 ML DEXAMETHASONE SODIUM PHOSPHATE (P.F.) 80MG/ML (8%) INJECTABLE 100 ML 40 ML DEXAMETHASONE SODIUM PHOSPHATE (P.F.) 8MG/ML (800MCG/0.1ML) INJECTABLE 0.1 ML DEXAMETHASONE SODIUM PHOSPHATE 40MG/ML INJECTABLE 50 ML DEXAMETHASONE SODIUM PHOSPHATE 4MG/ML INJECTABLE 100 ML 180 MLS 240 MLS 30 ML 60 ML DEXAMETHASONE SODIUM PHOSPHATE IN BSS (P.F.) 10MG/ML (1%) INJECTABLE 1 ML DEXAMETHASONE SODIUM PHOSPHATE, 30ML VIAL** 4MG/ML INJECTABLE 30 ML DEXAMETHASONE SOLUTION - NACL, P.F. 0.1% OPHTHALMIC 15 ML DEXAMETHASONE, SDPF - (0.07ML SYRINGE, 30G, 1/2") 80MG/ML INJECTABLE 0.35 ML 0.7 ML Rx #'s: 0406046 0397385 0366980 0395509 0387345 0387381 0387586 0387752 0391041 0391584 0394112 0394246 0395288 0397054 0397946 0399555 0400910 0401208 0403442 0404123 0408115 0388847 0388144 0388144 0395892 0389202 0373332 0378850 0388550 0392222 0373332 0378850 0388550 0373332 0373332 0378850 0358046 0376175 0392337 0375442 0392337 0377047 0381838 0388945 0407636 0371528 0375458 0375458 0400150 0368414 0366367 0389059 0392819 0407227 0368231 0390906 0405998 0364593 0409797 0364593 Class II Lack of Assurance of Sterility: Franck's Lab Inc. initiated a recall of all Sterile Human Drugs distributed between 11/21/2011 and 05/21/2012 because FDA environmental sampling revealed the presence of microorganisms and fungal growth in the clean room where sterile products were prepared. Franck's Lab Inc., d.b.a. Franck's Compounding Lab
Drugs DEXAMETHASONE/BACTERIOSTATIC WATER IONTOPHORESIS 0.5MG/5ML(0.1MG/ML) INJECTABL 30 ML (1 PRODUCT) 40 ML DEXAMETHASONE SDPF (0.1ML SYRINGE, 31G, 5/16" ) 0.4MG/ML INJECTABLE 0.3 ML 0.5 ML DEXAMETHASONE SODIUM PHOSPHATE (P.F.) 10MG/ML (1%) INJECTABLE 0.05 ML 1 ML 16 ML 2 ML 24 ML 3 ML 32 ML 8 ML DEXAMETHASONE SODIUM PHOSPHATE (P.F.) 4MG/ML (0.4%) INJECTABLE 0.4 ML 2 ML 3 ML 5 ML 6 ML DEXAMETHASONE SODIUM PHOSPHATE (P.F.) 80MG/ML (8%) INJECTABLE 100 ML 40 ML DEXAMETHASONE SODIUM PHOSPHATE (P.F.) 8MG/ML (800MCG/0.1ML) INJECTABLE 0.1 ML DEXAMETHASONE SODIUM PHOSPHATE 40MG/ML INJECTABLE 50 ML DEXAMETHASONE SODIUM PHOSPHATE 4MG/ML INJECTABLE 100 ML 180 MLS 240 MLS 30 ML 60 ML DEXAMETHASONE SODIUM PHOSPHATE IN BSS (P.F.) 10MG/ML (1%) INJECTABLE 1 ML DEXAMETHASONE SODIUM PHOSPHATE, 30ML VIAL** 4MG/ML INJECTABLE 30 ML DEXAMETHASONE SOLUTION - NACL, P.F. 0.1% OPHTHALMIC 15 ML DEXAMETHASONE, SDPF - (0.07ML SYRINGE, 30G, 1/2") 80MG/ML INJECTABLE 0.35 ML 0.7 ML Rx #: 0400257 Class II Lack of Assurance of Sterility: Franck's Lab Inc. initiated a recall of all Sterile Human Drugs distributed between 11/21/2011 and 05/21/2012 because FDA environmental sampling revealed the presence of microorganisms and fungal growth in the clean room where sterile products were prepared. Franck's Lab Inc., d.b.a. Franck's Compounding Lab
Drugs DEXPANTHENOL 250MG/ML INJECTABLE 100 ML, 120 ML, 360 ML, 450 ML (4 DIFFERENT PRODUCTS) Rx #: 0370657 0391175 0397241 0397241 Class II Lack of Assurance of Sterility: Franck's Lab Inc. initiated a recall of all Sterile Human Drugs distributed between 11/21/2011 and 05/21/2012 because FDA environmental sampling revealed the presence of microorganisms and fungal growth in the clean room where sterile products were prepared. Franck's Lab Inc., d.b.a. Franck's Compounding Lab
Drugs DEXTROSE/PROCAINE HCL P.F. 12%/1% INJECTABLE 400 ML ( 1 PRODUCT) Rx #: 0395208 Class II Lack of Assurance of Sterility: Franck's Lab Inc. initiated a recall of all Sterile Human Drugs distributed between 11/21/2011 and 05/21/2012 because FDA environmental sampling revealed the presence of microorganisms and fungal growth in the clean room where sterile products were prepared. Franck's Lab Inc., d.b.a. Franck's Compounding Lab
Drugs DIAZEPAM (IM/IV) 1MG/ML INJECTABLE 40 ML, 60 ML; DIAZEPAM (IM/IV) 5MG/ML INJECTABLE 2 ML, 20 ML, 300 ML; DIAZEPAM 2.5MG/ML INJECTABLE 40 ML; DIAZEPAM 2MG/ML INJECTABLE 100 ML, 50 ML (8 DIFFERENT PRODUCTS) Rx #'s:C0406509 C0404925 C0405367 C0399957 C0399948 C0398336 C0403450 C0405679 C0409032 C0398683 C0399922 C0404944 Class II Lack of Assurance of Sterility: Franck's Lab Inc. initiated a recall of all Sterile Human Drugs distributed between 11/21/2011 and 05/21/2012 because FDA environmental sampling revealed the presence of microorganisms and fungal growth in the clean room where sterile products were prepared. Franck's Lab Inc., d.b.a. Franck's Compounding Lab
Drugs DICLOFENAC SODIUM, SDPF - (0.1ML SYRINGE, 30G, 1/2") 500MCG/0.1ML INJECTABLE 0.5 ML, 2 ML, 4 ML (3 DIFFERENT PRODUCTS) Rx #'s: 0392224 0378833 0402369 0360916 0402369 Class II Lack of Assurance of Sterility: Franck's Lab Inc. initiated a recall of all Sterile Human Drugs distributed between 11/21/2011 and 05/21/2012 because FDA environmental sampling revealed the presence of microorganisms and fungal growth in the clean room where sterile products were prepared. Franck's Lab Inc., d.b.a. Franck's Compounding Lab
Drugs DIPHENHYDRAMINE 25MG/ML INJECTABLE 90 ML; DIPHENHYDRAMINE 50MG/ML INJECTABLE 10 ML, 100 ML, 108 ML, 120 MLS, 25 ML, 32 ML, 60 ML, 90 ML, 90 MLS; DIPHENHYDRAMINE, SDV, 25X1ML** 50MG/ML INJECTABLE 25 ML (11 DIFFERENT PRODUCTS) Rx #'s: 0387528 0395197 0389191 0390909 0406810 0409865 0388591 0388594 0388595 0388597 0388598 0388599 0388602 0388604 0391126 0390909 0390909 0397860 0400856 0402992 0404849 0406843 Class II Lack of Assurance of Sterility: Franck's Lab Inc. initiated a recall of all Sterile Human Drugs distributed between 11/21/2011 and 05/21/2012 because FDA environmental sampling revealed the presence of microorganisms and fungal growth in the clean room where sterile products were prepared. Franck's Lab Inc., d.b.a. Franck's Compounding Lab
Drugs DMPS 250MG/10ML INJECTABLE 20 ML, 30 ML; DMPS 50MG/ML (500MG/10ML) INJECTABLE 10 ML, 5 ML (4 DIFFERENT PRODUCTS) Rx #'s: 0405733 0353173 0349837 0392673 Class II Lack of Assurance of Sterility: Franck's Lab Inc. initiated a recall of all Sterile Human Drugs distributed between 11/21/2011 and 05/21/2012 because FDA environmental sampling revealed the presence of microorganisms and fungal growth in the clean room where sterile products were prepared. Franck's Lab Inc., d.b.a. Franck's Compounding Lab
Drugs DMSO / BUPIVACAINE HCL 50%/0.5% INJECTABLE 100 ML, 50 ML; DMSO 100% INJECTABLE 100 ML; DMSO FORTIFIED IRRIGATION - W/O HEPARIN SOLUTION 350 ML; DMSO FORTIFIED IRRIGATION 50%/0.01%/44%/1% SOLUTION 1000 ML, 1200 ML, 150 ML, 200 ML, 250 ML, 300 ML, 400 ML, 500 ML, 600 ML; DMSO FORTIFIED IRRIGATION 50%/44%/1% SOLUTION 50 ML; DMSO FORTIFIED IRRIGATION W/LIDOCAINE 50%/0.01%/44%/1%/1% SOLUTION 250 ML; DMSO IRRIGATION - NACHO3 50% SOLUTION 100 ML, 300 ML, 400 ML, 500 ML, 600 ML; DMSO W/LIDOCAINE 50%/0.5% SOLUTION 100 ML, 1200 ML, 150 ML, 200 ML, 250 ML, 2500 ML, 30 ML, 300 ML, 400 ML, 50 ML, 500 ML, 600 ML (32 DIFFERENT PRODUCTS) Rx #'s: 0368127 0368127 0396422 0394589 0389031 0397908 0405717 0377092 0395743 0399094 0364766 0377092 0383467 0395743 0399094 0385418 0377092 0391512 0397919 0409221 0395743 0383467 0410209 0353611 0397908 0409800 0372333 0381650 0388770 0357605 0399192 0357605 0357605 0399192 0357605 0370950 0384873 0389326 0357967 0399100 0356533 0361811 0368706 0392087 0401999 0402000 0402006 0405708 0408219 0361811 0368706 0371146 0379509 0380104 0384873 0393576 0403473 0405271 0405527 0371848 0388317 0399025 0408772 0398966 0398276 0352407 0371146 0375451 0377804 0383961 0384873 0388317 0391725 0392087 0393569 0396968 0371146 0375451 0368706 0399665 0401355 0402666 0407936 0362282 0388317 0368311 Class II Lack of Assurance of Sterility: Franck's Lab Inc. initiated a recall of all Sterile Human Drugs distributed between 11/21/2011 and 05/21/2012 because FDA environmental sampling revealed the presence of microorganisms and fungal growth in the clean room where sterile products were prepared. Franck's Lab Inc., d.b.a. Franck's Compounding Lab
Drugs DMSO/HEPARIN 50%/20,000U/25ML SOLUTION 100 ML, 25 ML; DMSO/HEPARIN 50%/5000U/50ML SOLUTION 300 ML, 400 ML (4 DIFFERENT PRODUCTS) Rx #'s: 0405376 0386923 0397004 0397004 Class II Lack of Assurance of Sterility: Franck's Lab Inc. initiated a recall of all Sterile Human Drugs distributed between 11/21/2011 and 05/21/2012 because FDA environmental sampling revealed the presence of microorganisms and fungal growth in the clean room where sterile products were prepared. Franck's Lab Inc., d.b.a. Franck's Compounding Lab
Drugs DMSO/HEPARIN/METHYLPREDNISOLONE 50%/5000U/40MG/50ML SOLUTION 300 MLS (1 PRODUCT) Rx #: 0384672 Class II Lack of Assurance of Sterility: Franck's Lab Inc. initiated a recall of all Sterile Human Drugs distributed between 11/21/2011 and 05/21/2012 because FDA environmental sampling revealed the presence of microorganisms and fungal growth in the clean room where sterile products were prepared. Franck's Lab Inc., d.b.a. Franck's Compounding Lab
Drugs DMSO/VITAMIN C/GLUTATHIONE SOLUTION 6.25%/1.25%/1.25% OPHTHALMIC 10 ML, 15 ML, 5 ML (3 DIFFERENT PRODUCTS) Rx #'s: 0393533 0387959 0366146 0395006 0401280 0408662 Class II Lack of Assurance of Sterility: Franck's Lab Inc. initiated a recall of all Sterile Human Drugs distributed between 11/21/2011 and 05/21/2012 because FDA environmental sampling revealed the presence of microorganisms and fungal growth in the clean room where sterile products were prepared. Franck's Lab Inc., d.b.a. Franck's Compounding Lab
Drugs DOXORUBICIN HCL, LYOPHILIZED 10MG VIAL 2 VIAL; DOXORUBICIN HCL, LYOPHILIZED 50MG VIAL 1 VIAL, 10 VIAL, 5 VIAL (4 DIFFERENT PRODUCTS) Rx #'s: 0393869 0393871 0356246 0357036 Class II Lack of Assurance of Sterility: Franck's Lab Inc. initiated a recall of all Sterile Human Drugs distributed between 11/21/2011 and 05/21/2012 because FDA environmental sampling revealed the presence of microorganisms and fungal growth in the clean room where sterile products were prepared. Franck's Lab Inc., d.b.a. Franck's Compounding Lab
Drugs DROPTAINER STERILE PLASTIC (2 X 7ML) 10 BOTTLE 4 PK (2 DIFFERENT PRODUCTS) Rx #'s: T0395419 T0393096 Class II Lack of Assurance of Sterility: Franck's Lab Inc. initiated a recall of all Sterile Human Drugs distributed between 11/21/2011 and 05/21/2012 because FDA environmental sampling revealed the presence of microorganisms and fungal growth in the clean room where sterile products were prepared. Franck's Lab Inc., d.b.a. Franck's Compounding Lab
Drugs EDETATE DISODIUM PF IN BSS 3% OPHTHALMIC 10 ML; EDETATE DISODIUM SOLUTION IN ARTIFICIAL TEARS 0.05% OPHTHALMIC 10 ML (2 DIFFERENT PRODUCTS) Rx #'s: 0397185 0408097 Class II Lack of Assurance of Sterility: Franck's Lab Inc. initiated a recall of all Sterile Human Drugs distributed between 11/21/2011 and 05/21/2012 because FDA environmental sampling revealed the presence of microorganisms and fungal growth in the clean room where sterile products were prepared. Franck's Lab Inc., d.b.a. Franck's Compounding Lab
Drugs EDTA DISODIUM SOLUTION 33.6MG/ML (0.1 MOLAR) OPHTHALMIC 15 ML; EDTA CALCIUM DISODIUM (PRESERVATIVE FREE) 150MG/ML INJECTABLE 100 ML, 2400 ML, 500 ML; EDTA CALCIUM DISODIUM SOLUTION 2% OPHTHALMIC 5 ML; EDTA DISODIUM (P.F.) 150MG/ML INJECTABLE 1000 ML, 1200 ML, 1500 ML, 400 ML, 500 ML, 900 ML; EDTA DISODIUM (PRESERVATIVE FREE) 150MG/ML INJECTABLE 1000 ML, 2000 ML, 8000 ML; EDTA DISODIUM (PRESERVATIVE FREE) 3%/ML INJECTABLE 12 ML; EDTA DISODIUM IN NATURAL TEARS 1.5% OPHTHALMIC 5 ML; EDTA DISODIUM IN NATURAL TEARS 3% OPHTHALMIC 15 ML, 30 ML (18 DIFFERENT PRODUCTS) Rx #'s: 0388316 0388963 0389126 0389635 0391611 0406215 0395252 0392864 0395978 0390748 0390748 0390748 0391630 0391630 0390748 0400319 0388489 0388489 0389320 0390209 0403997 0382211 0381428 Class II Lack of Assurance of Sterility: Franck's Lab Inc. initiated a recall of all Sterile Human Drugs distributed between 11/21/2011 and 05/21/2012 because FDA environmental sampling revealed the presence of microorganisms and fungal growth in the clean room where sterile products were prepared. Franck's Lab Inc., d.b.a. Franck's Compounding Lab
Drugs EPINEPHRINE **(25X1ML AMPULS) 1:1000 1MG/ML INJECTABLE 25 ML; EPINEPHRINE HCL SOLUTION 1% OPHTHALMIC 10 ML, 20 ML; EPIINEPHRINE P.F. (SULFITE-FREE) 1:1,000 (1MG/ML) INJECTABLE 1 ML, 2 ML, 20 ML, 25 ML, 3 ML, 30 ML, 4 ML, 5 ML, 50 ML; EPINEPHRINE PF IN BSS, OPHTHALMIC (CONTAINS SULFITES) 1:1000 (1MG/ML) INJECTABLE 15 ML, 16 ML, 30 ML (15 DIFFERENT PRODUCTS) Rx #'s: 0397555 0397557 0382534 0400837 0407829 0390562 0390562 0395167 0397757 0396775 0394599 0390562 0396775 0390562 0390562 0396775 0389984 0387701 0389984 Class II Lack of Assurance of Sterility: Franck's Lab Inc. initiated a recall of all Sterile Human Drugs distributed between 11/21/2011 and 05/21/2012 because FDA environmental sampling revealed the presence of microorganisms and fungal growth in the clean room where sterile products were prepared. Franck's Lab Inc., d.b.a. Franck's Compounding Lab
Drugs ESTRADIOL 25MG PELLETS 1 PELLET, 15 PEL, 15 PELLET, 2 PELLET, 2 TAB, 3 PELLET, 4 PELLET, 6 PELL, 6 PELLET; ESTRADIOL 50MG PELLETS 1 PELELT, 1 PELLET, 4 PELLET, 6 PELLET; ESTRADIOL CYPIONATE 5MG/ML INJECTABLE 5 ML; ESTRADIOL VALERATE IN COTTONSEED OIL 40 MG/ML INJECTABLE 10 ML; ESTRADIOL VALERATE IN SESAME OIL 40 MG/ML INJECTABLE 10 ML (16 DIFFERENT PRODUCTS) Rx #'s: 0389464 0398833 0399748 0402917 0402926 0405892 0404079 0404086 0392875 0398067 0403137 0403795 0404506 0408694 0404895 0387492 0389813 0390461 0391264 0391818 0391961 0392952 0393766 0395543 0396232 0396925 0397181 0397313 0397959 0399219 0400227 0400749 0400845 0401497 0401998 0402465 0402997 0403162 0405298 0405330 0405341 0406903 0407419 0408021 0409309 0409791 0402406 0402414 0389982 0389976 0407175 0386101 0391782 0394584 0399576 0403154 0403358 0404795 0406532 0409701 0410127 0400234 0389894 0369509 0407537 0387936 0388504 0401671 0391774 0395019 Class II Lack of Assurance of Sterility: Franck's Lab Inc. initiated a recall of all Sterile Human Drugs distributed between 11/21/2011 and 05/21/2012 because FDA environmental sampling revealed the presence of microorganisms and fungal growth in the clean room where sterile products were prepared. Franck's Lab Inc., d.b.a. Franck's Compounding Lab
Drugs ETHYL ALCOHOL 10% INJECTABLE 30 ML; ETHYL ALCOHOL 100%INJECTABLE 10 ML, 100 ML, 20 ML, 40 ML, 5 ML, 60 ML; ETHYL ALCOHOL 20% INJECTABLE 5 ML; ETHYL ALCOHOL 5% INJECTABLE 180 ML, 30 ML; ETHYL ALCOHOL 95% INJECTABLE 10 ML, 8 ML; ETHYL ALCOHOL OPHTHALMIC 40% INJECTABLE 50 ML (13 DIFFERENT PRODUCTS) Rx #'s: 0378831 0387603 0391286 0391286 0391286 0396237 0391286 0401965 0392266 0406349 0360543 0406198 0360543 0398555 Class II Lack of Assurance of Sterility: Franck's Lab Inc. initiated a recall of all Sterile Human Drugs distributed between 11/21/2011 and 05/21/2012 because FDA environmental sampling revealed the presence of microorganisms and fungal growth in the clean room where sterile products were prepared. Franck's Lab Inc., d.b.a. Franck's Compounding Lab
Drugs ETOMIDATE 0.2% (2MG/ML) INJECTABLE 20 ML (1 PRODUCT) Rx #: 0403172 Class II Lack of Assurance of Sterility: Franck's Lab Inc. initiated a recall of all Sterile Human Drugs distributed between 11/21/2011 and 05/21/2012 because FDA environmental sampling revealed the presence of microorganisms and fungal growth in the clean room where sterile products were prepared. Franck's Lab Inc., d.b.a. Franck's Compounding Lab
Drugs FENTANYL, P.F. 100MCG/ML INJECTABLE 12 ML, 2 ML, 30 ML, 60 ML; FENTANYL, P.F. 50MCG/ML (100MCG/2ML) INJECTABLE 100 ML, 120 ML, 150 ML, 20 ML, 200 ML, 24 ML, 250 ML, 30 ML, 300 ML, 40 ML, 400 ML, 50 ML, 60 ML; FENTANYL, WITH PRESERVATIVES 50MCG/ML INJECTABLE 30 ML (18 DIFFERENT PRODUCTS) Rx #'s:N0395099 N0389078 N0389083 N0389084 N0389085 N0389086 N0389089 N0389090 N0389093 N0389095 N0389097 N0389099 N0389100 N0390325 N0390326 N0390328 N0390329 N0390331 N0390332 N0390333 N0390338 N0390377 N0390380 N0390382 N0390383 N0390385 N0390390 N0390393 N0392339 N0392343 N0392344 N0392345 N0392347 N0392349 N0392351 N0392353 N0392354 N0392355 N0392357 N0392360 N0392363 N0392364 N0392367 N0392368 N0392370 N0392372 N0392374 N0392375 N0397646 N0397796 N0397797 N0397798 N0397802 N0397803 N0397804 N0397805 N0397806 N0397807 N0397990 N0397993 N0397994 N0397996 N0397997 N0398016 N0398017 N0398019 N0398020 N0398021 N0396955 N0398306 N0405187 N0401002 N0396784 N0398527 N0400271 N0400917 N0407735 N0409318 N0398310 N0408255 N0399153 N0404847 N0398297 N0399447 N0403452 N0406065 N0409741 N0397353 N0398612 N0406345 N0408105 N0393498 N0395106 N0401234 N0402072 N0402652 N0406677 N0397637 N0400888 N0398823 N0399918 N0400676 N0404455 N0398592 N0409187 N0393520 N0394243 N0406426 N0407548 N0397583 Class II Lack of Assurance of Sterility: Franck's Lab Inc. initiated a recall of all Sterile Human Drugs distributed between 11/21/2011 and 05/21/2012 because FDA environmental sampling revealed the presence of microorganisms and fungal growth in the clean room where sterile products were prepared. Franck's Lab Inc., d.b.a. Franck's Compounding Lab
Drugs FLUORESCEIN/INDOCYANINE, LYOPHILIZED 200MG/10MG VIAL INJECTABLE 12 VIAL, 20 VIAL, 24 VIAL; FLUORESCEIN/INDOCYANINE, LYOPHILIZED 200MG/15MG VIAL INJECTABLE 23 VIAL, 25 VIAL, 30 VIAL, 7 VIAL; FLUORESCEIN/INDOCYANINE, LYOPHILIZED 200MG/5MG VIAL INJECTABLE 1 VIAL, 10 VIAL, 12 VIAL, 13 VIAL, 15 VIAL, 2 VIAL, 20 VIAL, 24 VIAL, 3 VIAL, 30 VIAL, 40 VIAL, 41 VIAL, 5 VIAL, 50 VIAL, 6 VIAL, 7 VIAL, 9 VIAL; FLUORESCEIN/INDOCYANINE, LYOPHILIZED 300MG/5MG VIAL INJECTABLE 10 VIAL, 15 VIAL, 20 VIAL; FLUORESCEIN/INDOCYANINE, LYOPHILIZED 300MG/7.5MG VIAL INJECTABLE 20 vials, 6 VIAL; FLUORESCEIN/INDOCYANINE, LYOPHILIZED 400MG/15MG VIAL INJECTABLE 10 VIAL, 14 VIAL, 15 VIAL, 16 VIAL, 2 VIAL, 20 VIAL, 21 VIAL, 25 VIAL, 250 VIAL, 3 VIAL, 30 VIAL, 32 VIAL, 4 VIAL, 40 VIAL, 5 VIAL, 50 VIAL, 6 VIAL, 8 VIALS, 9 VIAL; FLUORESCEIN/INDOCYANINE, LYOPHILIZED 500MG/25MG VIAL INJECTABLE 1 VIAL, 12 VIAL, 2 VIAL, 23 VIAL, 30 VIAL, 6 VIAL, 8 VIAL; FLUORESCEIN/INDOCYANINE, LYOPHILIZED 600MG/12.5MG VIAL INJECTABLE 58 VIAL, 680 VIAL, 692 VIAL, 724 VIAL, 750 VIAL; FLUORESCEIN/INDOCYANINE, LYOPHILIZED 600MG/15MG VIAL INJECTABLE 2 VIAL, 3 VIAL; FLUORESCEIN/INDOCYANINE, LYOPHYLIZED 1000MG/10MG INJECTABLE 100 VIAL, 137 VIAL, 140 VIAL, 153 VIAL, 200 VIAL, 47 VIAL, 60 VIAL, 63 VIAL (70 DIFFEENT PRODUCTS) Rx #'s: 0387858 0387858 0387858 0360970 0360970 0360970 0360970 0394556 0394868 0388495 0389506 0401222 0406557 0393109 0390858 0406557 0394195 0384679 0390858 0401222 0386372 0393109 0387476 0387651 0394195 0396927 0400464 0384679 0389105 0389105 0389105 0387476 0384679 0388495 0389105 0387476 0392323 0393109 0394195 0390858 0389105 0391704 0391704 0391704 0365030 0392325 0359065 0364511 0365182 0366253 0366265 0370058 0384847 0387893 0387894 0388887 0392782 0393234 0393654 0395364 0400787 0401230 0408490 0394164 0350907 0354075 0364511 0370058 0384847 0387894 0388887 0392782 0393234 0394910 0395364 0410310 0394449 0388820 0354075 0364600 0370665 0393234 0393654 0394164 0395364 0400787 0370665 0349864 0384847 0403576 0370058 0366253 0388820 0370058 0370058 0373554 0370665 0393234 0359065 0366368 0373554 0384847 0387893 0387894 0388887 0393915 0394164 0390169 0394074 0394164 0400289 0389633 0394449 0394557 0388093 0382934 0379184 0379184 0388093 0394557 0388093 0390228 0390228 0390228 0390228 0390228 0403847 0403851 0387650 0396924 0358285 0376244 0397588 0404422 0404430 0376244 0376244 0376244 0376244 0376244 0376244 0376244 Class II Lack of Assurance of Sterility: Franck's Lab Inc. initiated a recall of all Sterile Human Drugs distributed between 11/21/2011 and 05/21/2012 because FDA environmental sampling revealed the presence of microorganisms and fungal growth in the clean room where sterile products were prepared. Franck's Lab Inc., d.b.a. Franck's Compounding Lab
Drugs FLUOROURACIL (5-FU) SOLUTION 5% OPHTHALMIC 100 ML; FLUOROURACIL (5-FU) SOLUTION IN ARTIFICIAL TEARS 1% OPHTHALMIC 15 ML; FLUOROURACIL (5-FU) SOLUTION, P.F. 0.001% (10MCG/ML) OPHTHALMIC 20 ML, 30 ML; FLUOROURACIL P.F. 5% INJECTABLE 1000 ML,500 ML, 600 ML; FLUOROURACIL SOLUTION PF 1% OPHTHALMIC 10 ML, 20 ML, 25 ML, 5 ML; FLUOROURACIL, P.F. 1% INJECTABLE 40 ML (12 DIFFERENT PRODUCTS) Rx #'s: 0397776 0377720 0388566 0388566 0379930 0396960 0402574 0379930 0391427 0391427 0391427 0391427 0408750 Class II Lack of Assurance of Sterility: Franck's Lab Inc. initiated a recall of all Sterile Human Drugs distributed between 11/21/2011 and 05/21/2012 because FDA environmental sampling revealed the presence of microorganisms and fungal growth in the clean room where sterile products were prepared. Franck's Lab Inc., d.b.a. Franck's Compounding Lab
Drugs FOLIC ACID 10MG/ML INJECTABLE 60 ML (1 PRODUCT) Rx #: 0398930 Class II Lack of Assurance of Sterility: Franck's Lab Inc. initiated a recall of all Sterile Human Drugs distributed between 11/21/2011 and 05/21/2012 because FDA environmental sampling revealed the presence of microorganisms and fungal growth in the clean room where sterile products were prepared. Franck's Lab Inc., d.b.a. Franck's Compounding Lab
Drugs FORMIX 100MCG / 30MG / 1MG INJECTABLE 10 ML, 10 MLS, 5 ML; FORMIX 100MCG / 30MG / 2MG INJECTABLE 10 ML (4 DIFFERENT PRODUCTS) Rx #'s: 0357028 0372461 0374296 0376008 0397681 0407302 0392293 0371718 0396669 Class II Lack of Assurance of Sterility: Franck's Lab Inc. initiated a recall of all Sterile Human Drugs distributed between 11/21/2011 and 05/21/2012 because FDA environmental sampling revealed the presence of microorganisms and fungal growth in the clean room where sterile products were prepared. Franck's Lab Inc., d.b.a. Franck's Compounding Lab
Drugs FORSKOLIN/PAPAVARINE/PHENTOLAMINE 200MCG/40MG/3MG/ML INJECTABLE 5 ML; FORSKOLIN/PAPAVARINE/PHENTOLAMINE/ALPROSTADIL 100MCG/30MG/1MG/30MCG/ML INJECTABL 10 ML; (2 DIFFERENT PRODUCTS) Rx #'s: 0402610 0406777 0407425 0407640 Class II Lack of Assurance of Sterility: Franck's Lab Inc. initiated a recall of all Sterile Human Drugs distributed between 11/21/2011 and 05/21/2012 because FDA environmental sampling revealed the presence of microorganisms and fungal growth in the clean room where sterile products were prepared. Franck's Lab Inc., d.b.a. Franck's Compounding Lab
Drugs FORSKOLIN/PHENTOLAMINE 200MCG / 2MG INJECTABLE 5 ML (1 PRODUCT) Rx #: 0395658 Class II Lack of Assurance of Sterility: Franck's Lab Inc. initiated a recall of all Sterile Human Drugs distributed between 11/21/2011 and 05/21/2012 because FDA environmental sampling revealed the presence of microorganisms and fungal growth in the clean room where sterile products were prepared. Franck's Lab Inc., d.b.a. Franck's Compounding Lab
Drugs GANCYCLOVIR, SDPF - (30G, 1/2" SYRINGE) 20MG/ML INJECTABLE 1 ML (1 PRODUCT) Rx #: 0397447 Class II Lack of Assurance of Sterility: Franck's Lab Inc. initiated a recall of all Sterile Human Drugs distributed between 11/21/2011 and 05/21/2012 because FDA environmental sampling revealed the presence of microorganisms and fungal growth in the clean room where sterile products were prepared. Franck's Lab Inc., d.b.a. Franck's Compounding Lab
Drugs G-C-P 0.1%/0.1%/0.05% SOLUTION 250 ML, 250 MLS, 500 ML (3 DIFFERENT PRODUCTS) Rx #'s: 0400975 0409215 0395770 0359811 Class II Lack of Assurance of Sterility: Franck's Lab Inc. initiated a recall of all Sterile Human Drugs distributed between 11/21/2011 and 05/21/2012 because FDA environmental sampling revealed the presence of microorganisms and fungal growth in the clean room where sterile products were prepared. Franck's Lab Inc., d.b.a. Franck's Compounding Lab
Drugs GENTAMICIN 40MG/ML (80MG/2ML) INJECTABLE 20 ML, 40 ML, 48 ML, 50 ML; GENTAMICIN / SODIUM BICARBONATE (STERILE) 480MG/LITER SOLUTION 1000 ML; GENTAMICIN /CLINDAMYCIN /POLYMIXIN B/STERILE WATER 0.1%/0.1%/0.05% SOLUTION 250 ML, 500 ML; GENTAMICIN DROPS (FORTIFIED) 14MG/ML (1.4%) OPHTHALMIC 10 ML; GENTAMICIN DROPS (FORTIFIED) 15MG/ML (1.5%) OPHTHALMIC 10 ML, 15 ML; GENTAMICIN DROPS (FORTIFIED) 18MG/ML (1.8%) OPHTHALMIC 5 ML; GENTAMICIN IRRIGATION 1GM/LITER SOLUTION 2000 ML; GENTAMICIN IRRIGATION 480MG/LITER SOLUTION 1000 ML, 2000 ML; GENTAMICIN***(80MGX2ML) 40MG/ML INJECTABLE 100 ML, 100 MLS, 100 VIAL, 12 ML, 14 ML, 150 ML, 200 ML, 25, 40 ML, 50 ML, 50 MLS, 50 VIALS (26 DIFFERENT PRODUCTS) Rx #'s: 0402163 0401103 0361246 0374339 0400819 0401878 0376767 0357627 0358558 0385752 0387435 0388683 0398782 0389025 0389135 0394537 0400051 0410208 0389025 0388231 0391057 0405031 0393211 0393211 0388792 0384288 0407535 0378398 0378398 0377517 0378503 0378504 0380549 0381687 0383319 0385206 0390165 0390166 0390930 0392241 0396501 0396675 0397835 0398312 0398392 0398889 0402538 0402842 0405320 0408916 0378060 0378502 0385165 0399334 0399337 0399340 0399345 0399348 0408326 0405172 0396619 0393974 0378077 0380549 0385218 0399333 0399346 0399349 0399351 0399353 0399354 0399356 0399358 0399361 0399362 0392241 0405640 0402538 0396501 0377276 0377517 0377857 0378077 0379493 0380295 0380549 0380551 0381687 0385218 0387271 0387274 0387280 0387282 0389068 0390166 0390930 0391460 0391463 0391466 0391469 0391576 0391881 0392180 0392182 0392184 0395103 0395519 0396501 0404869 0409343 0409489 0409490 0409492 0410150 0410384 0367933 0395652 0396783 0408328 0402535 Class II Lack of Assurance of Sterility: Franck's Lab Inc. initiated a recall of all Sterile Human Drugs distributed between 11/21/2011 and 05/21/2012 because FDA environmental sampling revealed the presence of microorganisms and fungal growth in the clean room where sterile products were prepared. Franck's Lab Inc., d.b.a. Franck's Compounding Lab
Drugs GLUTATHIONE INHALATION 30MG/ML SOLUTION 120 ML, 60 ML; GLUTATHIONE P.F. 200MG/ML INJECTABLE 10 ML, 100 ML, 14 ML, 150 ML, 175 ML, 20 ML, 30 ML, 300 ML, 40 ML, 40 MLS, 50 ML, 58 MLS, 70 ML; GLUTATHIONE P.F. 50MG/ML (500MG/10ML) INJECTABLE 100 ML, 150 ML, 20 ML, 40 ML, 60 ML; GLUTATHIONE-FFC 100MG/ML INJECTABLE 20 ML (21 DIFFERENT PRODUCTS) Rx #'s: 0389833 0394741 0392912 0388244 0397159 0399176 0388244 0405177 0409379 0392912 0397159 0377235 0408837 0402247 0388244 0397159 0403342 0404418 0388244 0393276 0393276 0351537 0393276 0351537 0393276 0390499 Class II Lack of Assurance of Sterility: Franck's Lab Inc. initiated a recall of all Sterile Human Drugs distributed between 11/21/2011 and 05/21/2012 because FDA environmental sampling revealed the presence of microorganisms and fungal growth in the clean room where sterile products were prepared. Franck's Lab Inc., d.b.a. Franck's Compounding Lab
Drugs GLYCERIN 99.5% OPHTHALMIC 10 ML, 5 ML, 7.5 ML; GLYCERIN 100% OPHTHALMIC 15 ML (4 DIFFERENT PRODUCTS) Rx #'s: 0405776 0405779 0393390 0405545 Class II Lack of Assurance of Sterility: Franck's Lab Inc. initiated a recall of all Sterile Human Drugs distributed between 11/21/2011 and 05/21/2012 because FDA environmental sampling revealed the presence of microorganisms and fungal growth in the clean room where sterile products were prepared. Franck's Lab Inc., d.b.a. Franck's Compounding Lab
Drugs HYALURONIC ACID SODIUM SALT 10MG/ML INJECTABLE 100 ML, 20 ML; HYALURONIC ACID SODIUM SALT, P.F. 20MG/ML INJECTABLE 500 ML (3 DIFFERENT PRODUCTS) Rx #'s: 0399566 0389886 0407257 Class II Lack of Assurance of Sterility: Franck's Lab Inc. initiated a recall of all Sterile Human Drugs distributed between 11/21/2011 and 05/21/2012 because FDA environmental sampling revealed the presence of microorganisms and fungal growth in the clean room where sterile products were prepared. Franck's Lab Inc., d.b.a. Franck's Compounding Lab
Drugs HYALURONIDASE - PRESERVATIVE FREE 150 U/ML INJECTABLE 1 MLS, 10 MLS, 100 MLS, 12 MLS, 12.5 ML, 120 MLS, 15 MLS, 16 ML, 16 MLS, 2 MLS, 20 ML, 20 MLS, 24 MLS, 25 ML, 30 ML, 30 MLS, 36 MLS, 4 MLS, 40 MLS, 44 ML, 5 MLS, 50 ML, 50 MLS, 6 ML, 6 MLS, 60 MLS, 8 MLS, 80 MLS, 9 ML; HYALURONIDASE - PRESERVATIVE FREE 200 U/ML INJECTABLE 2 MLS; HYALURONIDASE / LIDOCAINE / BUPICAVAINE 7.1U/9.5MG/3.5MG/ML INJECTABLE 210 ML, 525 ML, 630 ML; HYALURONIDASE / LIDOCAINE 7.1U/9.5MG/ML INJECTABLE 105 ML, 210 ML; HYALURONIDASE 150 U/ML INJECTABLE 0.2 MLS, 0.3 MLS, 0.8 MLS, 1 MLS, 10 MLS, 12 MLS, 15 MLS, 20 MLS, 25 MLS, 3 ML, 4 ML, 40 MLS, 5 MLS, 50 MLS, 60 MLS, 8 MLS, 80 MLS; HYALURONIDASE NO PRES 100 U/ML INJECTABLE 24 MLS, 40 MLS (48 DIFFERENT PRODUCTS) Rx #'s: 0366959 0388654 0388657 0388658 0388660 0388661 0388662 0388664 0388665 0388667 0388669 0388670 0388672 0388673 0390311 0390330 0390334 0390337 0390340 0390343 0390346 0390348 0390355 0390357 0390359 0390362 0391423 0391429 0391430 0391432 0391438 0391439 0391442 0391448 0391449 0391450 0391453 0391455 0391456 0391458 0391462 0391465 0391467 0391470 0395839 0395841 0395843 0395846 0395850 0395852 0395865 0395867 0395868 0395873 0395874 0395875 0397179 0397189 0397193 0397195 0397203 0397205 0397209 0397210 0397213 0397214 0397216 0397218 0397220 0397223 0397226 0397228 0397229 0399091 0399093 0399097 0399098 0399102 0399140 0399141 0399142 0399147 0399151 0399154 0399843 0399847 0399849 0399850 0399853 0399858 0399859 0399863 0399866 0399870 0399872 0399873 0399877 0399879 0399880 0399881 0402800 0402801 0402802 0402805 0402806 0402808 0402811 0402813 0402815 0402816 0402817 0402818 0402819 0402820 0402821 0402822 0402824 0404680 0404683 0404684 0404686 0404687 0404689 0404690 0404691 0404692 0404693 0404695 0404698 0404701 0404704 0405948 0405949 0405951 0405954 0405955 0405958 0405959 0405963 0405964 0405965 0405967 0405969 0406682 0406685 0406688 0406690 0406691 0406695 0406698 0406702 0406703 0406705 0406709 0406713 0406716 0406719 0406721 0406727 0409290 0409291 0409294 0409297 0409299 0409304 0409305 0409306 0409307 0409308 0409310 0409312 0409313 0409315 0409689 0409691 0409695 0409698 0409699 0409715 0409717 0409718 0409721 0409723 0409729 0409733 0363730 0369336 0382310 0387728 0389871 0394063 0357268 0366414 0398896 0367820 0387644 0370181 0387728 0397783 0367820 0394280 0366959 0397783 0400745 0366414 0387644 0397783 0397783 0369339 0387728 0367820 0382310 0352468 0394551 0406837 0397783 0386976 0398395 0358143 0397783 0372798 0385858 0397783 0367820 0386976 0398032 0385858 0367820 0382402 0395305 0384431 0387955 0397783 0392988 Class II Lack of Assurance of Sterility: Franck's Lab Inc. initiated a recall of all Sterile Human Drugs distributed between 11/21/2011 and 05/21/2012 because FDA environmental sampling revealed the presence of microorganisms and fungal growth in the clean room where sterile products were prepared. Franck's Lab Inc., d.b.a. Franck's Compounding Lab
Drugs HYALURONIDASE / LIDOCAINE 7.1U/9.5MG/ML INJECTABLE 105 ML, 210 ML (6 DIFFERENT PRODUCTS) Rx #'s: 0359944 0359944 0408186 Class II Lack of Assurance of Sterility: Franck's Lab Inc. initiated a recall of all Sterile Human Drugs distributed between 11/21/2011 and 05/21/2012 because FDA environmental sampling revealed the presence of microorganisms and fungal growth in the clean room where sterile products were prepared. Franck's Lab Inc., d.b.a. Franck's Compounding Lab
Drugs HYALURONIDASE / LIDOCAINE / BUPICAVAINE 7.1U/9.5MG/3.5MG/ML INJECTABLE 210 ML, 525 ML, 630 ML; HYALURONIDASE/LIDOCAINE/EPI/BUPIVICAINE INJECTABLE 32 ML, 64 ML (5 DIFFERENT PRODUCTS) Rx #'s: 0359947 0408187 0359947 0389777 0389777 Class II Lack of Assurance of Sterility: Franck's Lab Inc. initiated a recall of all Sterile Human Drugs distributed between 11/21/2011 and 05/21/2012 because FDA environmental sampling revealed the presence of microorganisms and fungal growth in the clean room where sterile products were prepared. Franck's Lab Inc., d.b.a. Franck's Compounding Lab
Drugs HYALURONIDASE/METHYLPREDNISOLONE ACETATE, P.F. 37.5U/20MG/ML INJECTABLE 20 ML (1 PRODUCT) Rx #: 0383354 Class II Lack of Assurance of Sterility: Franck's Lab Inc. initiated a recall of all Sterile Human Drugs distributed between 11/21/2011 and 05/21/2012 because FDA environmental sampling revealed the presence of microorganisms and fungal growth in the clean room where sterile products were prepared. Franck's Lab Inc., d.b.a. Franck's Compounding Lab
Drugs HYDROCHLORIC ACID INJECTION 2MG/ML INJECTABLE 400 ML, 60 ML (2 DIFFERENT PRODUCTS) Rx #'s: 0389733 0398961 0398282 Class II Lack of Assurance of Sterility: Franck's Lab Inc. initiated a recall of all Sterile Human Drugs distributed between 11/21/2011 and 05/21/2012 because FDA environmental sampling revealed the presence of microorganisms and fungal growth in the clean room where sterile products were prepared. Franck's Lab Inc., d.b.a. Franck's Compounding Lab
Drugs HYDROGEN PEROXIDE PF 3% INJECTABLE 150 ML, 200 ML, 50 ML, 60 ML (4 DIFFERENT PRODUCTS) Rx #'s: 0401261 0371940 0396624 0401261 0402167 0387248 Class II Lack of Assurance of Sterility: Franck's Lab Inc. initiated a recall of all Sterile Human Drugs distributed between 11/21/2011 and 05/21/2012 because FDA environmental sampling revealed the presence of microorganisms and fungal growth in the clean room where sterile products were prepared. Franck's Lab Inc., d.b.a. Franck's Compounding Lab
Drugs HYDROMORPHONE P.F. 20MG/ML INTRATHECAL 40 ML; HYDROMORPHONE P.F. 25MG/ML INTRATHECAL 18 ML; HYDROMORPHONE P.F. 30MG/ML INTRATHECAL 18 ML; HYDROMORPHONE P.F. 50MG/ML INTRATHECAL 40 ML (4 DIFFERENT PRODUCTS) Rx #'s:N0393645 N0399634 N0398233 N0388437 N0395176 N0396644 N0403778 N0396442 Class II Lack of Assurance of Sterility: Franck's Lab Inc. initiated a recall of all Sterile Human Drugs distributed between 11/21/2011 and 05/21/2012 because FDA environmental sampling revealed the presence of microorganisms and fungal growth in the clean room where sterile products were prepared. Franck's Lab Inc., d.b.a. Franck's Compounding Lab
Drugs HYDROMORPHONE/BACLOFEN/BUPIVACAINE (0.9% NACL) 50MG/1000MCG/7.5MG/ML INTRATHECAL 18 ML; HYDROMORPHONE/BACLOFEN/BUPIVACAINE (0.9% NACL) 50MG/1500MCG/7.5MG/ML INTRATHECAL 18 ML; HYDROMORPHONE/BACLOFEN/BUPIVACAINE (0.9% SODIUM CHLORIDE) 50MG/500MCG/7.5MG/ML I 18 ML (3 DIFFEENT PRODUCTS) Rx #'s:N0391871 N0395248 N0400014 N0404731 N0404936 N0408940 N0387888 Class II Lack of Assurance of Sterility: Franck's Lab Inc. initiated a recall of all Sterile Human Drugs distributed between 11/21/2011 and 05/21/2012 because FDA environmental sampling revealed the presence of microorganisms and fungal growth in the clean room where sterile products were prepared. Franck's Lab Inc., d.b.a. Franck's Compounding Lab
Drugs HYDROMORPHONE/CLONIDINE P. F. 120MG/1.3MCG/ML INTRATHECAL 10 ML; HYDROMORPHONE/CLONIDINE P. F. 120MG/1.8MCG/ML INTRATHECAL 10 ML; HYDROMORPHONE/CLONIDINE P. F. 80MG/1.2MCG/ML INTRATHECAL 10 ML (3 DIFFERENT PRODUCTS) Rx #'s:N0395798 N0397394 N0392201 N0400799 N0403781 N0407180 N0390189 Class II Lack of Assurance of Sterility: Franck's Lab Inc. initiated a recall of all Sterile Human Drugs distributed between 11/21/2011 and 05/21/2012 because FDA environmental sampling revealed the presence of microorganisms and fungal growth in the clean room where sterile products were prepared. Franck's Lab Inc., d.b.a. Franck's Compounding Lab
Drugs HYDROXYPROGESTERONE CAPROATE 250MG/ML INJECTABLE 10 ML, 12 ML, 13 ML, 15 ML, 3 ML, 30 ML, 4 ML, 5 ML, 6 ML, 7 ML, 9 ML (11 DIFFERENT PRODUCTS) Rx #'s: 0389566 0391189 0400011 0363726 0384953 0389818 0389944 0391513 0394424 0398045 0399810 0400508 0400659 0400899 0402416 0406767 0408616 0408784 0409002 0394645 0404250 0404253 0383078 0390794 0396149 0407773 0380431 0400011 0408013 0385258 0396543 0400011 0386991 0398045 Class II Lack of Assurance of Sterility: Franck's Lab Inc. initiated a recall of all Sterile Human Drugs distributed between 11/21/2011 and 05/21/2012 because FDA environmental sampling revealed the presence of microorganisms and fungal growth in the clean room where sterile products were prepared. Franck's Lab Inc., d.b.a. Franck's Compounding Lab
Drugs HYPERTONIC SOLUTION IN PRESERVED WATER 10% INJECTABLE 50 ML (1 PRODUCT) Rx #: 0388007 Class II Lack of Assurance of Sterility: Franck's Lab Inc. initiated a recall of all Sterile Human Drugs distributed between 11/21/2011 and 05/21/2012 because FDA environmental sampling revealed the presence of microorganisms and fungal growth in the clean room where sterile products were prepared. Franck's Lab Inc., d.b.a. Franck's Compounding Lab
Drugs INDOCYANINE GREEN - KIT 15MG INJECTABLE 1 KIT, 100 KIT, 12 KIT, 20 KIT, 50 KIT, 6 KIT, 75 KIT, 8 KIT; INDOCYANINE GREEN - KIT 1MG INJECTABLE 1 KIT, 10 `KIT, 10 KIT, 100 KIT, 18 VIAL, 2 KIT (51 DIFFERENT PRODUCTS) 2 VIAL 20 KIT 22 KITS 25 KITS 3 KITS 3 VIALS 4 VIALS 5 KIT 50 KIT 50 KITS 6 KIT 60 KIT 8 KIT INDOCYANINE GREEN - KIT 25MG INJECTABLE 1 KIT 6 KIT INDOCYANINE GREEN - KIT 30MG INJECTABLE 10 KIT 14 KIT 25 KIT 5 KIT INDOCYANINE GREEN - KIT 5MG INJECTABLE 1 KIT 10 KIT 12 KIT 15 KIT 15 VIAL 2 KIT 20 KIT 25 KIT 3 KIT 4 KIT 5 KIT 6 KIT 8 KIT INDOCYANINE GREEN, LYOPHILIZED 15MG VIAL 1 VIAL INDOCYANINE GREEN, LYOPHILIZED 1MG VIAL 2 VIAL 5 VIAL INDOCYANINE GREEN, LYOPHILIZED 5MG VIAL 1 VIAL 2 KIT Rx #'s: 0392321 0394025 0388514 0401919 0350642 0394025 0388514 0394025 0388514 0390732 0390733 0390734 0390735 0390736 0390737 0390738 0380350 0368327 0374556 0367241 0389528 0387672 0387673 0388017 0388019 0388022 0388506 0388512 0388515 0392608 0392615 0392616 0392619 0392621 0396198 0396215 0396216 0396229 0396231 0399438 0399439 0399442 0399445 0403009 0403010 0403011 0403012 0403013 0406259 0406260 0406262 0406344 0407979 0407983 0407994 0407995 0407997 0389528 0380350 0391097 0391097 0391097 0394711 0394711 0396280 0396282 0401229 0401451 0403261 0403264 0403265 0403266 0406344 0367241 0391097 0360638 0360913 0370332 0374556 0367241 0368572 0374556 0390415 0396119 0381037 0381037 0409349 0381037 0407487 0369244 0398000 0400203 0369244 0401228 0365406 0381433 0382639 0397201 0408640 0398000 0366257 0366257 0381433 0387899 0408486 0381433 0387899 0397201 0401228 0382639 0403456 0358087 0394872 0401833 0403472 0392320 0360357 Class II Lack of Assurance of Sterility: Franck's Lab Inc. initiated a recall of all Sterile Human Drugs distributed between 11/21/2011 and 05/21/2012 because FDA environmental sampling revealed the presence of microorganisms and fungal growth in the clean room where sterile products were prepared. Franck's Lab Inc., d.b.a. Franck's Compounding Lab
Drugs INSULIN, LO-DOSE (FROM HUMALOG) 10 UNITS/ML INJECTABLE 10 ML (1 PRODUCT) Rx #: 0399969 Class II Lack of Assurance of Sterility: Franck's Lab Inc. initiated a recall of all Sterile Human Drugs distributed between 11/21/2011 and 05/21/2012. FDA environmental sampling revealed the presence of microorganisms and fungal growth in the clean room where sterile products were prepared. Franck's Lab Inc., d.b.a. Franck's Compounding Lab
Drugs IOHEXOL 200MG IODINE/ML INJECTABLE 120 ML 300 ML 50 ML 600 ML 72 ML; IOHEXOL, 4ML VIAL 240MG IODINE/ML INJECTABLE 200 ML; IOHEXOL, 3ML VIAL 300MG IODINE/ML INJECTABLE 180 ML 600 ML 90 ML 900 ML (10 DIFFERENT PRODUCTS) Rx #'s: 0398081 0397941 0407446 0397941 0398081 0409508 0356693 0374227 0356693 0400766 0374227 Class II Lack of Assurance of Sterility: Franck's Lab Inc. initiated a recall of all Sterile Human Drugs distributed between 11/21/2011 and 05/21/2012. FDA environmental sampling revealed the presence of microorganisms and fungal growth in the clean room where sterile products were prepared. Franck's Lab Inc., d.b.a. Franck's Compounding Lab
Drugs IOPAMIDOL 41% INJECTABLE 198 ML 99 ML 50 ML 600 ML 72 ML; IOHEXOL, 4ML VIAL 240MG IODINE/ML INJECTABLE 200 ML; IOHEXOL, 3ML VIAL 300MG IODINE/ML INJECTABLE 180 ML 600 ML 90 ML 900 ML (2 DIFFERENT PRODUCTS) Rx #'s: 0377832 0377832 Class II Lack of Assurance of Sterility: Franck's Lab Inc. initiated a recall of all Sterile Human Drugs distributed between 11/21/2011 and 05/21/2012. FDA environmental sampling revealed the presence of microorganisms and fungal growth in the clean room where sterile products were prepared. Franck's Lab Inc., d.b.a. Franck's Compounding Lab
Drugs ISOSULFAN BLUE 1% INJECTABLE 10 ML 15 ML (2 DIFFERENT PRODUCTS) Rx #'s: 0384839 0384839 Class II Lack of Assurance of Sterility: Franck's Lab Inc. initiated a recall of all Sterile Human Drugs distributed between 11/21/2011 and 05/21/2012. FDA environmental sampling revealed the presence of microorganisms and fungal growth in the clean room where sterile products were prepared. Franck's Lab Inc., d.b.a. Franck's Compounding Lab
Drugs KETOROLAC TROMETHAMINE 30MG/ML INJECTABLE 10 ML 24 ML 500 ML; KETOROLAC TROMETHAMINE 60MG/ML INJECTABLE 48 ML; KETOROLAC TROMETHAMINE, 1ML SDV**25X1ML 30MG/ML INJECTABLE 50 ML 75 ML; KETOROLAC TROMETHAMINE, P.F. 60MG/ML INJECTABLE 10 ML (7 DIFFERENT PRODUCTS) Rx #'s: 0407225 0407852 0405175 0408193 0403243 0404737 0392573 0392575 0392577 0392575 0401951 0404831 Class II Lack of Assurance of Sterility: Franck's Lab Inc. initiated a recall of all Sterile Human Drugs distributed between 11/21/2011 and 05/21/2012. FDA environmental sampling revealed the presence of microorganisms and fungal growth in the clean room where sterile products were prepared. Franck's Lab Inc., d.b.a. Franck's Compounding Lab
Drugs LABETALOL HYDROCHLORIDE 5MG/ML INJECTABLE 100 ML 80 ML (2 DIFFERENT PRODUCTS) Rx #'s: 0386748 0389778 Class II Lack of Assurance of Sterility: Franck's Lab Inc. initiated a recall of all Sterile Human Drugs distributed between 11/21/2011 and 05/21/2012. FDA environmental sampling revealed the presence of microorganisms and fungal growth in the clean room where sterile products were prepared. Franck's Lab Inc., d.b.a. Franck's Compounding Lab
Drugs L-ARGININE 500MG/ML INJECTABLE 2500 ML 500 ML (2 DIFFERENT PRODUCTS) Rx #'s: 0382804 0356180 Class II Lack of Assurance of Sterility: Franck's Lab Inc. initiated a recall of all Sterile Human Drugs distributed between 11/21/2011 and 05/21/2012. FDA environmental sampling revealed the presence of microorganisms and fungal growth in the clean room where sterile products were prepared. Franck's Lab Inc., d.b.a. Franck's Compounding Lab
Drugs LEUCOVORIN, LYOPHILIZED 100 MG VIAL INJECTABLE 1 VIAL 10 VIAL 100 VIAL 2 VIAL 24 VIAL 30 VIAL 50 VIAL 60 VIAL 76 VIAL; LEUCOVORIN, LYOPHILIZED 350 MG VIAL INJECTABLE 10 VIAL 15 VIAL 20 VIAL 22 VIAL 28 VIAL 30 VIAL 4 VIAL 40 VIAL 5 VIAL 50 VIAL 8 VIAL; LEUCOVORIN, LYOPHILIZED 500 MG VIAL INJECTABLE 10 VIAL 14 VIAL 15 VIAL 17 VIAL 2 VIAL 20 VIAL 23 VIAL 25 VIAL 27 VIAL 3 VIAL 30 VIAL 33 VIAL 36 VIAL 5 VIAL 50 VIAL (35 DIFFERENT PRODUCTS) Rx #'s: 0403290 0405427 0382085 0403290 0382085 0405142 0391560 0391560 0382085 0362356 0362504 0376747 0398606 0405426 0362504 0362504 0376747 0402778 0405426 0395599 0395599 0405112 0406366 0388985 0391567 0396672 0405426 0395599 0398606 0360280 0385032 0390726 0402210 0398232 0360280 0362394 0393068 0403288 0360025 0369905 0379934 0393068 0402985 0403256 0399150 0360025 0372389 0399150 0402985 0399150 0403288 0372389 0393068 0398232 0360280 0362394 0393068 0398232 Class II Lack of Assurance of Sterility: Franck's Lab Inc. initiated a recall of all Sterile Human Drugs distributed between 11/21/2011 and 05/21/2012. FDA environmental sampling revealed the presence of microorganisms and fungal growth in the clean room where sterile products were prepared. Franck's Lab Inc., d.b.a. Franck's Compounding Lab
Drugs LEVOFLOXACIN, P.F. (PREMIXED SOLUTION) 5MG/ML INJECTABLE 1200 ML 500 ML 700 ML 800 ML LEVOFLOXACIN, P.F. 25MG/ML(500MG/20ML) INJECTABLE 300 ML 500 ML (6 DIFFERENT PRODUCTS) Rx #'s: 0392592 0392592 0392592 0392592 0391541 0391541 Class II Lack of Assurance of Sterility: Franck's Lab Inc. initiated a recall of all Sterile Human Drugs distributed between 11/21/2011 and 05/21/2012. FDA environmental sampling revealed the presence of microorganisms and fungal growth in the clean room where sterile products were prepared. Franck's Lab Inc., d.b.a. Franck's Compounding Lab
Drugs LEVOTHYROXINE SODIUM 325MCG/ML (0.325MG/ML) INJECTABLE 15 ML (1 PRODUCT) Rx #'s: 0370408 0408889 Class II Lack of Assurance of Sterility: Franck's Lab Inc. initiated a recall of all Sterile Human Drugs distributed between 11/21/2011 and 05/21/2012. FDA environmental sampling revealed the presence of microorganisms and fungal growth in the clean room where sterile products were prepared. Franck's Lab Inc., d.b.a. Franck's Compounding Lab
Drugs LIDOCAINE HCL (STERILE) 4% JELLY 120 ML 30 ML; LIDOCAINE HCL 4% SOLUTION 200 ML 300 ML 500 ML 600 ML; LIDOCAINE HCL 1% INJECTABLE 100 ML 1000 ML 1200 ML 1250 ML 150 ML 1500 ML 180 ML 20 ML 200 ML 2000 ML 240 ML 250 ML 2500 ML 300 ML 350 ML 360 ML 400 ML 480 ML 50 ML 500 ML 60 ML 600 ML 720 ML 750 ML 7500 ML 90 ML; LIDOCAINE HCL 10% INJECTABLE 1000 ML; LIDOCAINE HCL IN BSS - P.F. OPHTHALMIC 1% INJECTABLE 30 ML; LIDOCAINE HCL W/EPI (25X30ML) MDV *** 1%-1:100000 INJECTABLE 150 MLS 180 MLS 50 VIALS; LIDOCAINE HCL, AQUEOUS 2% INJECTABLE 100 ML 1000 ML 120 ML 1200 GM 1200 ML 150 ML 1500 ML 20 ML 200 ML 2000 ML 240 ML 250 ML 2500 ML 300 ML 40 ML 450 ML 480 ML 50 ML 500 ML 600 ML 80 ML; LIDOCAINE HCL, AQUEOUS PF 2% INJECTABLE 1200 ML 1500 ML 1600 ML 200 ML 250 ML 50 ML 500 ML 600 ML 900 ML; LIDOCAINE HCL, AQUEOUS, BUFFERED, P.F. 2% INJECTABLE 1000 ML 500 ML; LIDOCAINE HCL, P.F. 0.5% INJECTABLE 1000 ML; LIDOCAINE HCL, P.F. 1% INJECTABLE 100 ML 12 ML 120 ML 125 ML 150 ML 24 ML 240 ML 2500 ML 2670 ML 30 ML 300 ML 40 ML 48 ML 50 ML 6 ML 60 ML 720 ML 80 ML 900 ML; LIDOCAINE HCL, P.F. 4% INJECTABLE 100 ML 1000 ML 125 ML 225 ML 240 ML 75 ML LIDOCAINE HCL/METHYLCELLULOSE 1%/2% JELLY 2 ML; LIDOCAINE HCL/METHYLCELLULOSE 2%/2% JELLY 1000 ML 1000 MLS 12000 ML 200 ML 2000 ML 2000 MLS 3000 ML 4000 ML 500 ML 5000 ML 6000 ML 750 ML; LIDOCAINE HCL/METHYLCELLULOSE 4%/2% JELLY 1000 ML; LIDOCAINE HCL/METHYLCELLULOSE 5%/2% JELLY 1000 ML; LIDOCAINE HCL/METHYLCELLULOSE 8%/2% JELLY 1000 ML (111 DIFFERENT PRODUCTS) Rx #'s: 0367755 0397544 0397544 0394203 0394203 0353087 0394203 0394203 0391064 0396617 0396618 0397379 0397665 0389435 0397604 0398197 0400182 0406428 0406441 0407299 0408671 0392392 0392866 0395109 0397604 0398121 0406401 0406428 0391064 0392866 0391064 0392394 0397379 0397401 0396330 0409785 0392392 0409993 0389435 0392394 0394007 0398254 0398371 0398197 0397564 0392532 0397401 0406158 0408033 0388839 0398070 0390935 0391064 0392392 0400496 0392394 0391064 0401695 0394973 0409350 0389048 0392392 0395192 0395322 0396495 0397014 0397235 0397286 0398200 0410339 0408395 0392392 0396495 0402468 0405322 0400938 0398892 0404270 0391064 0403246 0407249 0406513 0406511 0388935 0398116 0398651 0400184 0404681 0396015 0406879 0408191 0407760 0398152 0392177 0396015 0396776 0397935 0398690 0388570 0404681 0396331 0386589 0392123 0400499 0406879 0397574 0387654 0387657 0392123 0389739 0392177 0388570 0389520 0405648 0395417 0408169 0388570 0386589 0398344 0398897 0399058 0404400 0406370 0406409 0387654 0387657 0388315 0395460 0397237 0398140 0401098 0388570 0392120 0405324 0405865 0398386 0396384 0398522 0407403 0395328 0407403 0401899 0395328 0396384 0400983 0385425 0385425 0408240 0398953 0398955 0399006 0397926 0397701 0398953 0406581 0397701 0398955 0397926 0403958 0395327 0399741 0399741 0398231 0398955 0395209 0395209 0395209 0398953 0398955 0408343 0408356 0408359 0408361 0398953 0398955 0399741 0398953 0395327 0403237 0398228 0403237 0403822 0403955 0403237 0404870 0352507 0354115 0355699 0357889 0359365 0360370 0364979 0369341 0371280 0372079 0373472 0374032 0374306 0376181 0378274 0380074 0381850 0385344 0385547 0386110 0386788 0387127 0387422 0387464 0387859 0388713 0389087 0389291 0389369 0392010 0392179 0393703 0393791 0394288 0395465 0395688 0396321 0397535 0399096 0400643 0400805 0400842 0400849 0401048 0401101 0401253 0402339 0403298 0405184 0405477 0405647 0406833 0406870 0409282 0403815 0384363 0398902 0354644 0359373 0359556 0361151 0365492 0374306 0384183 0385520 0385547 0387466 0389030 0389369 0389936 0390088 0390875 0391203 0391252 0391254 0391255 0391808 0392555 0395499 0396125 0397244 0401048 0401553 0402814 0403285 0404205 0404211 0404219 0406766 0358069 0401639 0363813 0386485 0387583 0390418 0390538 0391203 0393542 0394622 0401048 0408256 0348902 0363945 0365492 0366731 0382057 0392179 0396006 0399798 0407366 0365954 0404604 0354990 0363945 0385338 0395499 0400889 0379753 0389066 0393699 0365954 0391256 0380645 0353540 0395979 0409426 Class II Lack of Assurance of Sterility: Franck's Lab Inc. initiated a recall of all Sterile Human Drugs distributed between 11/21/2011 and 05/21/2012. FDA environmental sampling revealed the presence of microorganisms and fungal growth in the clean room where sterile products were prepared. Franck's Lab Inc., d.b.a. Franck's Compounding Lab
Drugs LIDOCAINE HCL/BUPIVACAINE HCL PF 1%/0.375% OPHTHALMIC 30 ML 48 ML 60 ML 90 ML; LIDOCAINE HCL/BUPIVACAINE/HYALURONIDASE PF 0.83%/0.312%/16.67U/ML OPHTHALMIC 30 ML 48 ML 60 ML 90 ML; LIDOCAINE/BUPIVACAINE/HYALURONIDASE PF 1.776%/0.335%/22.22UNITS/ML OPHTHALMIC 30 ML 60 ML (8 DIFFERENT PRODUCTS) Rx #'s: 0370177 0370177 0370177 0387585 0370177 0387584 0387584 0387584 0387584 0370176 0370176 Class II Lack of Assurance of Sterility: Franck's Lab Inc. initiated a recall of all Sterile Human Drugs distributed between 11/21/2011 and 05/21/2012. FDA environmental sampling revealed the presence of microorganisms and fungal growth in the clean room where sterile products were prepared. Franck's Lab Inc., d.b.a. Franck's Compounding Lab
Drugs LIDOCAINE HCL/EPINEPHRINE IN BSS - P.F., SULFITE-FREE 0.75%/0.025% INJECTABLE 24 ML 6 ML; LIDOCAINE HCL/EPINEPHRINE, P.F., SULFITE-FREE 2%/1:100,000 (0.001%) INJECTABLE 10 ML 40 ML; LIDOCAINE HCL/EPINEPHRINE. 2%/1:100,000 (0.001%) INJECTABLE 100 ML 1200 ML 300 ML 80 ML; LIDOCAINE/EPINEPHRINE 1%/0.00025% OPHTHALMIC 30 ML 60 ML 90 ML; LIDOCAINE/EPINEPHRINE, P.F. (FOR DILUTION WITH BSS+) 1.71%/0.057% OPHTHALMIC 14 ML 7 ML (8 DIFFERENT PRODUCTS) Rx #'s: 0397942 0397942 0395256 0395256 0387634 0397219 0400108 0387634 0370170 0370170 0370170 0389690 0389690 Class II Lack of Assurance of Sterility: Franck's Lab Inc. initiated a recall of all Sterile Human Drugs distributed between 11/21/2011 and 05/21/2012. FDA environmental sampling revealed the presence of microorganisms and fungal growth in the clean room where sterile products were prepared. Franck's Lab Inc., d.b.a. Franck's Compounding Lab
Drugs LIDOCAINE/EPINEPHRINE/BUPIVACAINE, PF 1%/0.00025%/0.375% OPHTHALMIC 30 ML 48 ML 60 ML 90 ML; LIDOCAINE/EPINEPHRINE/BUPIVACAINE, PF 1%/0.0005%/0.25% OPHTHALMIC 30 ML 48 ML 60 ML 90 ML (8 DIFFERENT PRODUCTS) Rx #'s: 0370173 0370173 0370173 0370173 0371532 0371532 0371532 0371532 Class II Lack of Assurance of Sterility: Franck's Lab Inc. initiated a recall of all Sterile Human Drugs distributed between 11/21/2011 and 05/21/2012. FDA environmental sampling revealed the presence of microorganisms and fungal growth in the clean room where sterile products were prepared. Franck's Lab Inc., d.b.a. Franck's Compounding Lab
Drugs LIDOCAINE/SODIUM BICARBONATE/HEPARIN IRRIGATION 10.6MG/16.8MG/2667U/ML SOLUTIO 90 ML (1 PRODUCT) Rx #: 0394097 Class II Lack of Assurance of Sterility: Franck's Lab Inc. initiated a recall of all Sterile Human Drugs distributed between 11/21/2011 and 05/21/2012. FDA environmental sampling revealed the presence of microorganisms and fungal growth in the clean room where sterile products were prepared. Franck's Lab Inc., d.b.a. Franck's Compounding Lab
Drugs LIDOCAINE/TETRACAINE OPHTHALMIC 4%/0.5% SOLUTION 10 ML 15 ML 20 ML 200 ML 240 ML 300 ML 400 ML (7 DIFFERENT PRODUCTS) Rx #'s: 0387816 0387171 0387357 0401493 0372169 0401493 0401493 Class II Lack of Assurance of Sterility: Franck's Lab Inc. initiated a recall of all Sterile Human Drugs distributed between 11/21/2011 and 05/21/2012. FDA environmental sampling revealed the presence of microorganisms and fungal growth in the clean room where sterile products were prepared. Franck's Lab Inc., d.b.a. Franck's Compounding Lab
Drugs LISSAMINE GREEN SOLUTION 1% OPHTHALMIC 10 ML (1 PRODUCT) Rx #: 0391580 Class II Lack of Assurance of Sterility: Franck's Lab Inc. initiated a recall of all Sterile Human Drugs distributed between 11/21/2011 and 05/21/2012. FDA environmental sampling revealed the presence of microorganisms and fungal growth in the clean room where sterile products were prepared. Franck's Lab Inc., d.b.a. Franck's Compounding Lab
Drugs LITHIUM CHLORIDE 5MG/ML INJECTABLE 30 ML (1 PRODUCT) Rx #'s: 0370323 0408943 Class II Lack of Assurance of Sterility: Franck's Lab Inc. initiated a recall of all Sterile Human Drugs distributed between 11/21/2011 and 05/21/2012. FDA environmental sampling revealed the presence of microorganisms and fungal growth in the clean room where sterile products were prepared. Franck's Lab Inc., d.b.a. Franck's Compounding Lab
Drugs LORAZEPAM 2MG/ML INJECTABLE 10 ML 20 ML 200 ML (3 DIFFERENT PRODUCTS) Rx #'s:C0404989 C0398689 C0403441 Class II Lack of Assurance of Sterility: Franck's Lab Inc. initiated a recall of all Sterile Human Drugs distributed between 11/21/2011 and 05/21/2012. FDA environmental sampling revealed the presence of microorganisms and fungal growth in the clean room where sterile products were prepared. Franck's Lab Inc., d.b.a. Franck's Compounding Lab
Drugs L-TRYPTOPHAN 15MG/ML INJECTABLE 60 ML (1 PRODUCT) Rx #: 0399563 Class II Lack of Assurance of Sterility: Franck's Lab Inc. initiated a recall of all Sterile Human Drugs distributed between 11/21/2011 and 05/21/2012. FDA environmental sampling revealed the presence of microorganisms and fungal growth in the clean room where sterile products were prepared. Franck's Lab Inc., d.b.a. Franck's Compounding Lab
Drugs MAGNESIUM CHLORIDE, PRESERVATIVE FREE 20% INJECTABLE 100 ML 1000 ML 500 ML 600 ML 750 ML; MAGNESIUM SULFATE 50% (500MG/ML) INJECTABLE 14 ML 20 ML 4 ML; MAGNESIUM SULFATE IN 5% DEXTROSE 1% (1GM/100ML) INJECTABLE 2400 ML; MAGNESIUM SULFATE IN 5% DEXTROSE 4% (2GM/50ML) INJECTABLE 1200 ML; MAGNESIUM SULFATE, P.F. 50% (500MG/ML) INJECTABLE 180 ML 240 ML 4 ML 6 ML (14 DIFFERENT PRODUCTS) Rx #'s: 0357871 0391634 0371936 0352518 0371936 0390747 0371936 0390747 0400018 0400326 0408192 0402171 0408101 0409503 0398622 0399780 0401796 0401796 0389109 0401003 0383611 Class II Lack of Assurance of Sterility: Franck's Lab Inc. initiated a recall of all Sterile Human Drugs distributed between 11/21/2011 and 05/21/2012. FDA environmental sampling revealed the presence of microorganisms and fungal growth in the clean room where sterile products were prepared. Franck's Lab Inc., d.b.a. Franck's Compounding Lab
Drugs MANNITOL 20% INJECTABLE 1250 ML 250 ML 2500 ML 400 ML; MANNITOL 25% INJECTABLE 1200 ML 300 ML 350 ML 400 ML 600 ML (9 DIFFERENT PRODUCTS) Rx #'s: 0391527 0391528 0393746 0391527 0391528 0393746 0403451 0404796 0397463 0402780 0402781 0402208 0396691 0402780 Class II Lack of Assurance of Sterility: Franck's Lab Inc. initiated a recall of all Sterile Human Drugs distributed between 11/21/2011 and 05/21/2012. FDA environmental sampling revealed the presence of microorganisms and fungal growth in the clean room where sterile products were prepared. Franck's Lab Inc., d.b.a. Franck's Compounding Lab
Drugs MEPIVACAINE HCL/EPINEPHRINE. 2%/1:100,000 (0.001%) INJECTABLE 30 ML 60 ML; MEPIVICAINE HCL 3% (30MG/ML) INJECTABLE 6 MLS (3 DIFFERENT PRODUCTS) Rx #'s: 0392297 0392297 0395407 Class II Lack of Assurance of Sterility: Franck's Lab Inc. initiated a recall of all Sterile Human Drugs distributed between 11/21/2011 and 05/21/2012. FDA environmental sampling revealed the presence of microorganisms and fungal growth in the clean room where sterile products were prepared. Franck's Lab Inc., d.b.a. Franck's Compounding Lab
Drugs METHIONINE / INOSITOL / CHOLINE CHLORIDE 25MG/75MG/75MG/ML INJECTABLE 30 ML; METHIONINE/INOSITOL/CHOLINE CHLORIDE 0.8%/1.6%/1.6% INJECTABLE 180 ML 24 ML 240 ML 270 ML 30 ML 90 ML METHIONINE/INOSITOL/CHOLINE CHLORIDE 25MG/50MG/50MG/ML INJECTABLE 120 ML 300 ML METHIONINE/INOSITOL/CHOLINE CHLORIDE/B1/B2 0.8%/1.6%/1.6% INJECTABLE 60 ML (10 DIFFERENT PRODUCTS) Rx #'s: 0391307 0387323 0394852 0390852 0391092 0391452 0391582 0387323 0387323 0402850 0409602 0388849 0395801 0401312 0362629 0393748 0405277 0391772 Class II Lack of Assurance of Sterility: Franck's Lab Inc. initiated a recall of all Sterile Human Drugs distributed between 11/21/2011 and 05/21/2012. FDA environmental sampling revealed the presence of microorganisms and fungal growth in the clean room where sterile products were prepared. Franck's Lab Inc., d.b.a. Franck's Compounding Lab
Drugs METHIONINE/INOSITOL/CHOLINE CHLORIDE/CHROM/B12 (C) 0.8/1.6/1.6/0.0001/0.03% INJE 10 ML 200 ML 30 ML 50 ML; METHIONINE/INOSITOL/CHOLINE CHLORIDE/CHROM/B12 (M) 0.8/1.6/1.6/0.0001/0.03% INJE 10 ML 150 ML 180 ML 30 ML 360 ML 4 ML 5 ML; METHIONINE/INOSITOL/CHOLINE CHLORIDE/CHROM/VIT B-12 0.8/1.6/1.6/0.0001/0.03% IN 30 ML; METHIONINE/INOSITOL/CHOLINE CHLORIDE/CHROMIUM CHLORIDE 0.8/1.6/1.6/0.0001/0.03% 100 ML 30 ML 80 ML; METHIONINE/INOSITOL/CHOLINE CHLORIDE/VIT B12 0.8%/1.6%/1.6%/1200MCG/ML INJECTABL 30 ML; METHIONINE/INOSITOL/CHOLINE CL/B6/B12/CHROM/ (C) 25/50/50/100/1MG/4MCG 5 ML; METHIONINE/INOSITOL/CHOLINE/CHROMIUM W/O B-12 0.8/1.6/1.6/0.0001% INJECTABLE 30 ML (18 DIFFERENT PRODUCTS) Rx #'s: 0391506 0387832 0379379 0384684 0393073 0401183 0362996 0390985 0391304 0391536 0401641 0405794 0381389 0354014 0394430 0376201 0391434 0391655 0399075 0399950 0400595 0401944 0406909 0408906 0408911 0409594 0409904 0394430 0406648 0372200 0387977 0389172 0390806 0392300 0392584 0394307 0394757 0398054 0398203 0399720 0400786 0402244 0402746 0406118 0406497 0409911 0410108 0394860 0363347 0406812 0394712 0374379 0395812 0402219 0371817 0380501 0403485 Class II Lack of Assurance of Sterility: Franck's Lab Inc. initiated a recall of all Sterile Human Drugs distributed between 11/21/2011 and 05/21/2012. FDA environmental sampling revealed the presence of microorganisms and fungal growth in the clean room where sterile products were prepared. Franck's Lab Inc., d.b.a. Franck's Compounding Lab
Drugs METHYLCOBALAMIN 1,000MCG/ML INJECTABLE 10 ML 12 ML 15 ML 150 ML 2 ML 26 MLS 3 ML 30 ML 30 MLS 4 ML 40 ML 5 ML 6 ML 60 ML 80 ML 90 ML; METHYLCOBALAMIN ( DR HALL KIT) 1,000MCG/ML INJECTABLE 1 KIT 1 ML 10 ML 30 ML; METHYLCOBALAMIN ( DR HALL KIT) PRESERVATIVE FREE 1,000MCG/ML INJECTABLE 1 KIT; METHYLCOBALAMIN (PRESERV FREE) 1,000MCG/ML INJECTABLE 4 ML 8 ML; METHYLCOBALAMIN (PRESERV FREE) 25,000MCG/ML INJECTABLE 1.5 ML 3 ML 3.5 ML 60 ML; METHYLCOBALAMIN (PRESERVATIVE FREE) 25MG/ML INJECTABLE 30 ML 4 ML 8 ML; METHYLCOBALAMIN 5,000MCG/ML INJECTABLE 6 ML (31 DIFFERENT PRODUCTS) Rx #'s: 0391301 0391927 0397282 0399470 0391327 0392711 0394996 0401004 0395010 0388696 0389279 0401772 0402650 0404045 0404779 0406029 0408374 0403432 0392999 0395958 0396932 0398177 0405143 0405968 0407753 0365101 0365105 0365106 0365108 0371252 0371257 0371265 0371268 0371270 0382419 0391063 0391522 0393199 0403490 0406625 0406627 0406630 0409573 0409579 0409599 0403432 0387860 0388243 0389493 0390022 0390530 0391010 0391294 0391645 0392576 0392665 0392688 0392894 0393040 0393092 0393216 0393335 0393561 0393731 0395678 0396033 0397292 0398299 0398311 0399018 0400098 0400351 0400429 0400575 0400578 0400982 0401079 0401385 0401646 0401948 0402176 0402516 0402557 0402580 0402987 0403982 0405357 0405430 0405445 0407384 0407808 0407965 0408244 0408382 0408419 0408726 0408792 0409348 0381200 0361853 0392328 0394367 0399209 0390487 0391522 0397635 0381200 0380708 0352927 0361537 0367181 0371957 0373468 0375263 0376692 0378305 0381683 0382865 0384081 0385565 0387059 0387814 0388443 0388942 0388944 0389430 0391105 0397310 0400625 0402660 0403566 0407971 0407993 0388536 0388536 0368410 0388443 0396037 0397310 0400776 0404858 0405790 0404952 0369001 0367492 0400900 0371731 0371731 0371731 0400549 0406613 0392439 0392439 0401628 0392136 Class II Lack of Assurance of Sterility: Franck's Lab Inc. initiated a recall of all Sterile Human Drugs distributed between 11/21/2011 and 05/21/2012. FDA environmental sampling revealed the presence of microorganisms and fungal growth in the clean room where sterile products were prepared. Franck's Lab Inc., d.b.a. Franck's Compounding Lab
Drugs METHYLCOBALAMIN/FOLIC ACID - KIT 10MG/0.4MG/ML INJECTABLE 1 KIT METHYLCOBALAMIN/FOLIC ACID 1000MCG/0.4MG/ML INJECTABLE 10 ML METHYLCOBALAMIN/FOLIC ACID 10MG/0.4MG/ML INJECTABLE 10 ML 8 ML 8 MLS Rx #'s: 0369092 0390078 0388491 0404406 0399651 0373092 Class II Lack of Assurance of Sterility: Franck's Lab Inc. initiated a recall of all Sterile Human Drugs distributed between 11/21/2011 and 05/21/2012. FDA environmental sampling revealed the presence of microorganisms and fungal growth in the clean room where sterile products were prepared. Franck's Lab Inc., d.b.a. Franck's Compounding Lab
Drugs METHYLPREDNISOLONE ACETATE 100MG/ML INJECTABLE 50 ML; METHYLPREDNISOLONE ACETATE 80MG/ML INJECTABLE 1 ML 30 ML 6 ML 60 ML (5 DIFFERENT PRODUCTS) Rx #'s: 0398900 0399056 0404399 0391716 0391716 0391716 Class II Lack of Assurance of Sterility: Franck's Lab Inc. initiated a recall of all Sterile Human Drugs distributed between 11/21/2011 and 05/21/2012. FDA environmental sampling revealed the presence of microorganisms and fungal growth in the clean room where sterile products were prepared. Franck's Lab Inc., d.b.a. Franck's Compounding Lab
Drugs METHYLPREDNISOLONE ACETATE/LIDOCAINE HCL 40MG/10MG/ML INJECTABLE 100 ML 500 ML; METHYLPREDNISOLONE/LIDOCAINE 80MG/10MG/ML INJECTABLE 24 ML (3 DIFFERENT PRODUCTS) Rx #'s: 0408599 0401410 0402367 Class II Lack of Assurance of Sterility: Franck's Lab Inc. initiated a recall of all Sterile Human Drugs distributed between 11/21/2011 and 05/21/2012. FDA environmental sampling revealed the presence of microorganisms and fungal growth in the clean room where sterile products were prepared. Franck's Lab Inc., d.b.a. Franck's Compounding Lab
Drugs METOCLOPRAMIDE HCL 5MG/ML (10MG/2ML) INJECTABLE 2 ML 20 ML 200 ML 394 ML 400 ML 498 ML 500 ML 6 ML 600 ML (9 DIFFERENT PRODUCTS) Rx #'s: 0398595 0400957 0407855 0405521 0398595 0403109 0398595 0398595 0398595 0398595 Class II Lack of Assurance of Sterility: Franck's Lab Inc. initiated a recall of all Sterile Human Drugs distributed between 11/21/2011 and 05/21/2012. FDA environmental sampling revealed the presence of microorganisms and fungal growth in the clean room where sterile products were prepared. Franck's Lab Inc., d.b.a. Franck's Compounding Lab
Drugs MEYERS COCKTAIL INJECTABLE 30 ML; MEYERS COCKTAIL (DR. MORENO) INJECTABLE 90 ML; MEYERS COCKTAIL/ CALCIUM/VIT B1/ METHYLCOBALAMIN 1GM/5MG/1000MCG/500ML INJECTAB 250 ML 5 ML (4 DIFFERENT PRODUCTS) Rx #'s: 0406329 0374790 0399189 0399189 Class II Lack of Assurance of Sterility: Franck's Lab Inc. initiated a recall of all Sterile Human Drugs distributed between 11/21/2011 and 05/21/2012. FDA environmental sampling revealed the presence of microorganisms and fungal growth in the clean room where sterile products were prepared. Franck's Lab Inc., d.b.a. Franck's Compounding Lab
Drugs MIC - COMBO WITH METHYLCOBALAMIN 0.8/1.6/1.6/0.0001/0.03% INJECTABLE 10 ML 150 ML 30 ML; MIC COMBO + CHORIONIC GONADOTROPIN + B12 500U/40MCG/ML (125U/10MCG/0.25ML) INJEC 6 ML; MIC COMBO + CHORIONIC GONADOTROPIN, LYOPHILIZED 10,000 UNIT VIAL INJECTABLE 1 VIAL 10 VIAL 15 VIAL 2 VIAL 20 VIAL 4 VIAL 40 VIAL 5 VIAL 50 VIAL 6 VIAL 7 VIAL 8 VIAL MIC COMBO + CHORIONIC GONADOTROPIN, LYOPHILIZED(KIT) 10,000 UNIT VIAL INJECTABLE 1 KIT 2 KIT 4 KIT MIC COMBO + CHORIONIC GONADOTROPIN, LYOPHILIZED(KIT) II 10,000 UNIT VIAL INJECTA 1 KIT (20 DIFFERENT PRODUCTS) Rx #'s: 0406657 0405526 0391965 0393529 0390040 0362442 0370756 0378145 0386548 0393611 0394410 0394751 0394753 0395981 0397434 0398818 0399650 0399825 0399848 0399854 0400112 0401949 0404137 0404138 0404295 0405528 0405700 0407504 0407507 0407770 0408225 0408229 0408670 0410088 0370756 0376063 0391443 0397137 0397222 0397227 0402055 0406817 0391443 0362442 0375777 0390216 0392072 0392079 0392091 0395270 0395277 0395284 0398284 0400112 0403421 0370756 0391443 0362395 0374541 0375777 0395538 0407969 0391443 0374541 0376063 0395987 0395989 0397137 0402055 0387769 0370756 0374541 0376063 0374541 0383057 0385833 0387137 0387361 0387564 0387810 0388478 0390588 0391303 0392314 0392586 0393046 0393339 0394113 0394120 0395617 0395663 0395677 0396139 0397002 0397162 0397275 0397424 0397438 0397462 0397528 0397934 0398287 0398574 0398695 0398774 0399172 0399416 0399658 0399659 0399766 0399862 0400268 0400583 0400688 0400834 0401416 0401429 0401445 0401476 0401499 0401683 0401771 0402350 0403007 0403151 0403488 0403593 0403594 0403874 0404051 0404293 0404566 0404649 0404671 0404837 0404856 0404868 0404916 0405436 0405907 0405938 0406152 0406239 0406886 0407034 0407563 0408732 0381970 0388666 0402009 0376106 0393514 0405150 Class II Lack of Assurance of Sterility: Franck's Lab Inc. initiated a recall of all Sterile Human Drugs distributed between 11/21/2011 and 05/21/2012. FDA environmental sampling revealed the presence of microorganisms and fungal growth in the clean room where sterile products were prepared. Franck's Lab Inc., d.b.a. Franck's Compounding Lab
Drugs MIDAZOLAM 1MG/ML (5ML VIAL) INJECTABLE 100 ML; MIDAZOLAM 1MG/ML INJECTABLE 100 ML 108 ML 1250 ML 20 ML 292 ML 300 ML 40 ML 500 ML 90 ML; MIDAZOLAM 5MG/ML INJECTABLE 140 ML 150 ML 200 ML; MIDAZOLAM HCL ***(10X10ML) 5MG/ML INJECTABLE 100 MLS (13 DIFFERENT PRODUCTS) Rx #'s:C0392008 C0401692 C0401728 C0392845 C0398970 C0401801 C0402374 C0392845 C0396878 C0391291 C0402620 C0403051 C0396889 C0401679 C0402560 C0394688 Class II Lack of Assurance of Sterility: Franck's Lab Inc. initiated a recall of all Sterile Human Drugs distributed between 11/21/2011 and 05/21/2012. FDA environmental sampling revealed the presence of microorganisms and fungal growth in the clean room where sterile products were prepared. Franck's Lab Inc., d.b.a. Franck's Compounding Lab
Drugs MITOMYCIN 1MG/ML SOLUTION 160 ML 40 ML 80 ML; MITOMYCIN SOLUTION, STERILE 0.02% (200MCG/ML) OPHTHALMIC 0.5 ML 1 ML 1.5 ML 10 ML 12.5 ML 2 ML 2.5 ML 3 ML 30 ML 4 ML 5 ML 6 ML 7 ML; MITOMYCIN SOLUTION, STERILE 0.025% (250MCG/ML) OPHTHALMIC 2 ML 3 ML 4 ML 6 ML MITOMYCIN SOLUTION, STERILE 0.03% (300MCG/ML) OPHTHALMIC 2 ML 3 ML 4 ML 5 ML; MITOMYCIN SOLUTION, STERILE 0.04% (400MCG/ML) OPHTHALMIC 1 ML 10 ML 12 ML 2 ML 20 ML 3 ML 3.6 ML 4 ML 5 ML 5.4 ML 6 ML 7.2 ML; MITOMYCIN SOLUTION, STERILE 0.05% (500MCG/ML) OPHTHALMIC 1.5 ML 10 ML 15 ML 2 ML 3 ML 5 ML; MITOMYCIN SOLUTION, STERILE/BUFFERED 0.5MG/ML INJECTABLE 80 ML; MITOMYCIN, LYOPHILIZED 1MG INJECTABLE 1 VIAL 10 VIAL 12 VIAL 2 VIAL 2 VIALS 20 VIAL 20 vials 3 VIAL 3 VIALS 4 VIAL 4 VIALS 5 VIAL 5 VIALS 50 VIAL 6 VIAL 6 VIALS 8 VIAL 8 VIALS; MITOMYCIN, LYOPHILIZED (BUFFERED) 20MG INJECTABLE 1 VIAL 10 VIAL 12 VIAL 15 VIAL 16 VIAL 17 VIALS 18 VIAL 2 VIAL 20 VIAL 24 VIAL 24 VIALS 3 VIAL 30 VIAL 4 VIAL 5 VIAL 6 VIAL 6 VIALS 7 VIAL 7 VIALS 8 VIAL 8 VIALS; MITOMYCIN, LYOPHILIZED (BUFFERED) 40MG INJECTABLE 1 VIAL 1 VIALS 10 VIAL 10 VIALS 11 VIAL 12 VIAL 12 VIALS 13 VIAL 14 VIAL 15 `VIAL 15 VIAL 16 `VIAL 16 VIAL 17 `VIAL 18 VIAL 18 VIALS 2 `VIAL 2 VIAL 2 VIALS 20 VIAL 20 vials 23 `VIAL 23 VIAL 24 VIAL 3 VIAL 3 VIALS 30 VIAL 36 VIAL 4 VIAL 4 VIALS 40 VIAL 41 VIAL 5 VIAL 5 VIALS 50 VIAL 6 `VIAL 6 VIAL 6 VIALS 7 VIAL 8 VIAL 8 VIALS 9 VIAL; MITOMYCIN, LYOPHILIZED (BUFFERED) 5MG INJECTABLE 16 VIAL 2 VIAL 36 VIAL 4 VIAL; MITOMYCIN, LYOPHILIZED (OPHTHALMIC USE) 5MG INJECTABLE 4 VIAL 5 VIAL (130 DIFFERENT PRODUCTS) Rx #'s: 0385634 0395331 0382740 0391178 0392393 0402036 0404974 0406412 0348990 0389957 0389256 0398308 0400088 0402379 0368830 0381744 0391578 0393939 0368830 0394696 0394699 0394702 0400088 0370658 0374176 0374332 0377853 0396389 0409606 0397569 0363591 0363906 0364885 0368563 0370643 0374134 0388160 0390765 0391578 0397626 0397664 0405185 0368830 0390948 0360900 0364885 0370658 0371998 0377418 0386488 0387749 0390765 0391251 0392700 0396481 0404354 0408442 0408450 0384787 0364885 0399054 0399978 0407186 0357229 0368830 0369658 0378021 0388340 0392613 0392899 0395705 0396389 0397569 0398713 0401967 0363906 0369658 0374332 0385847 0395772 0389236 0354926 0372478 0389236 0403647 0369615 0372478 0403647 0398727 0356719 0384919 0358078 0405425 0364078 0361229 0355028 0363367 0387510 0393522 0396503 0396748 0402531 0403762 0381124 0389376 0390757 0397155 0403061 0407722 0402531 0409835 0360794 0367718 0380495 0399205 0392377 0375206 0366326 0389376 0390757 0392377 0375206 0393522 0399205 0406462 0392377 0381206 0379957 0386978 0387228 0381206 0405721 0379957 0386978 0388312 0355234 0395430 0396345 0397113 0397206 0398817 0364094 0390534 0395074 0381540 0355612 0356043 0381225 0389512 0398817 0406027 0398694 0390534 0397464 0356043 0364094 0376377 0390194 0390768 0396674 0402214 0408184 0393442 0364094 0396343 0399934 0379020 0404494 0365952 0385380 0379020 0406986 0363729 0366561 0404494 0371056 0407417 0393442 0392768 0394298 0394606 0397253 0403210 0403347 0406699 0407892 0408311 0355056 0361444 0367534 0367592 0373176 0379506 0388023 0398878 0366168 0367534 0373176 0385023 0389065 0408083 0410227 0367592 0388249 0396642 0398122 0408087 0385991 0367534 0378631 0390829 0392453 0395572 0395650 0395824 0396106 0396417 0399802 0401313 0401636 0407069 0408311 0367592 0405638 0408667 0356337 0387887 0387973 0398326 0354974 0385991 0360653 0368998 0383647 0386367 0401638 0404139 0401960 0352358 0363847 0368488 0376511 0379506 0388170 0394298 0395650 0395898 0396265 0402035 0405424 0388023 0390528 0398974 0363108 0368488 0376484 0377711 0379506 0383647 0383963 0383964 0386977 0389901 0395650 0396106 0397928 0398012 0399791 0400411 0401313 0401367 0404852 0406516 0406559 0409054 0409493 0358706 0366168 0388023 0385991 0356048 0390829 0399052 0404405 0358706 0364163 0368438 0373628 0378415 0380729 0384022 0384820 0384924 0386712 0387628 0387865 0388826 0389073 0390173 0390513 0390518 0390718 0391743 0392014 0394543 0394720 0396104 0396816 0397072 0397419 0399203 0399386 0400178 0401617 0404283 0404700 0407235 0408221 0409542 0395110 0354218 0356050 0356327 0357403 0358003 0358929 0359280 0369134 0369611 0376117 0377566 0383704 0385106 0387713 0387750 0390828 0390946 0391451 0393749 0394531 0395077 0396798 0398991 0399005 0402840 0403368 0403373 0403783 0406711 0378537 0398212 0356050 0359583 0364548 0356679 0357791 0363049 0364936 0367239 0369134 0370023 0373956 0376260 0376320 0378647 0385669 0386712 0386728 0387706 0390516 0390582 0393749 0393750 0395077 0396563 0398214 0399267 0399427 0400465 0403478 0405056 0406904 0408321 0408323 0408782 0408851 0409600 0358139 0361373 0389055 0399571 0386086 0395077 0404402 0409082 0357126 0396419 0395077 0354088 0377073 0385106 0390516 0390582 0394621 0401223 0395077 0391517 0395077 0406365 0395077 0354088 0409434 0395077 0353042 0355236 0355741 0357825 0365251 0372377 0375561 0379898 0382826 0383962 0384022 0384924 0389359 0389743 0390582 0392165 0393457 0394495 0394543 0395134 0395508 0395740 0396450 0396518 0396646 0396816 0398780 0398851 0404013 0404699 0404700 0405413 0408164 0395110 0400486 0408927 0357791 0359618 0364936 0369611 0384820 0387750 0392194 0397577 0399005 0400973 0401482 0408304 0359542 0395077 0395077 0354963 0360217 0391978 0398044 0398667 0404323 0353729 0353865 0354218 0356046 0358187 0359583 0365315 0367667 0371838 0373520 0374413 0375806 0376320 0376927 0381501 0382825 0383066 0383704 0383962 0384465 0385984 0386979 0387539 0387706 0388534 0389466 0389585 0389743 0393457 0394543 0394859 0395508 0395602 0395740 0396518 0399213 0401861 0402198 0404199 0406508 0406659 0407374 0407843 0408383 0409753 0397128 0357793 0363902 0390516 0401223 0401482 0358931 0352357 0355240 0359289 0364548 0364695 0367998 0368184 0372377 0373628 0375378 0378647 0378649 0381501 0384820 0385106 0386086 0386173 0386332 0386979 0388534 0388663 0390218 0390389 0390518 0391172 0391258 0391283 0391296 0391799 0393457 0393749 0395134 0396518 0404013 0404108 0404283 0406982 0407388 0408758 0410018 0378537 0359618 0364730 0371189 0401482 0354088 0359289 0362308 0364163 0368184 0375806 0378415 0381901 0383704 0385106 0387539 0387865 0388534 0388826 0389743 0389810 0390516 0391234 0391743 0392807 0394258 0395128 0396816 0399377 0404013 0405630 0389055 0371189 0394299 0395077 0353449 0353729 0353865 0354732 0354913 0354963 0355240 0355628 0356046 0356304 0357126 0357677 0357888 0359106 0359289 0359341 0359698 0361085 0361327 0362308 0362611 0363049 0364163 0368105 0368438 0371592 0373956 0374017 0375142 0375378 0375766 0375806 0376260 0376927 0378415 0378647 0378649 0381035 0381501 0382827 0385024 0385106 0385448 0385669 0385984 0386080 0386712 0387467 0387539 0387675 0387706 0387871 0389070 0389743 0389850 0390059 0390838 0390945 0391284 0391511 0391628 0391743 0392009 0392097 0392172 0392403 0392406 0392550 0392842 0393749 0394127 0394252 0394258 0394531 0394720 0395038 0395128 0395436 0395721 0396798 0396816 0396879 0396969 0397072 0397171 0397190 0397303 0397645 0398046 0398138 0398139 0398830 0398991 0399028 0399068 0399223 0399377 0400422 0400465 0400634 0400722 0400966 0401243 0401582 0401900 0401938 0402188 0402191 0402209 0403106 0403669 0404199 0404308 0404465 0404524 0404725 0404903 0404964 0405161 0405210 0405908 0406206 0406678 0406982 0407579 0407584 0408199 0408201 0408468 0409075 0409538 0409580 0409589 0409591 0409705 0409844 0409847 0410320 0378537 0388863 0389055 0394218 0399571 0354088 0387539 0399803 0401011 0404283 0352357 0354088 0354238 0355240 0357677 0359106 0359583 0363624 0368996 0369084 0384127 0385106 0386086 0386173 0388309 0388311 0388314 0389238 0392448 0394531 0395128 0396012 0396798 0396934 0398273 0399028 0399036 0400465 0400634 0400641 0400937 0401910 0402479 0402539 0403346 0404741 0405675 0405719 0406900 0407235 0407799 0408746 0408832 0367324 0380605 0388863 0354088 0376320 0378844 0379039 0384820 0385024 0386086 0391531 0394767 0395077 0404308 0390240 0383248 0400817 0383248 0395901 0402029 0388395 0394585 0391474 Class II Lack of Assurance of Sterility: Franck's Lab Inc. initiated a recall of all Sterile Human Drugs distributed between 11/21/2011 and 05/21/2012. FDA environmental sampling revealed the presence of microorganisms and fungal growth in the clean room where sterile products were prepared. Franck's Lab Inc., d.b.a. Franck's Compounding Lab
Drugs MITOMYCIN/BUPIVACAINE WITH EPI 1:200,000 0. 04MG/0.5% PER 0.3ML SYR INJECTABLE 3 ML (1 PRODUCT) Rx #: 0408260 Class II Lack of Assurance of Sterility: Franck's Lab Inc. initiated a recall of all Sterile Human Drugs distributed between 11/21/2011 and 05/21/2012. FDA environmental sampling revealed the presence of microorganisms and fungal growth in the clean room where sterile products were prepared. Franck's Lab Inc., d.b.a. Franck's Compounding Lab
Drugs MITOMYCIN/LIDOCAINE/EPINEPHRINE 0.04%/0.02%/0.1% INJECTABLE 5 ML; MITOMYCIN/LIDOCAINE/EPINEPHRINE 0.08MG/13.3MG/6.7MCG/ML INJECTABLE 0.2 ML (2 DIFFERENT PRODUCTS) Rx #'s: 0399208 0385915 Class II Lack of Assurance of Sterility: Franck's Lab Inc. initiated a recall of all Sterile Human Drugs distributed between 11/21/2011 and 05/21/2012. FDA environmental sampling revealed the presence of microorganisms and fungal growth in the clean room where sterile products were prepared. Franck's Lab Inc., d.b.a. Franck's Compounding Lab
Drugs MOLYBDENUM 250MCG/ML INJECTABLE 30 ML 60 ML (2 DIFFERENT PRODUCTS) Rx #'s: 0374326 0374326 Class II Lack of Assurance of Sterility: Franck's Lab Inc. initiated a recall of all Sterile Human Drugs distributed between 11/21/2011 and 05/21/2012. FDA environmental sampling revealed the presence of microorganisms and fungal growth in the clean room where sterile products were prepared. Franck's Lab Inc., d.b.a. Franck's Compounding Lab
Drugs MORPHINE SULFATE 2MG/ML INJECTABLE 10 ML; MORPHINE SULFATE MDV 10MG/ML INJECTABLE 10 ML 25 ML 30 ML; MORPHINE SULFATE, P.F. (0.9% SODIUM CHLORIDE) 50MG/ML INTRATHECAL 18 ML 40 ML; MORPHINE SULFATE, P.F. (0.9% SODIUM CHLORIDE) 15MG/ML INTRATHECAL 40 ML; MORPHINE SULFATE, P.F. (0.9% SODIUM CHLORIDE) 20MG/ML INTRATHECAL 18 ML 40 ML; MORPHINE SULFATE, P.F. (0.9% SODIUM CHLORIDE) 25MG/ML INTRATHECAL 20 ML 40 ML; MORPHINE SULFATE, P.F. (0.9% SODIUM CHLORIDE) 38MG/ML INTRATHECAL 50 ML; MORPHINE SULFATE, P.F. (0.9% SODIUM CHLORIDE) 5MG/ML INTRATHECAL 40 ML; MORPHINE SULFATE, P.F. 10MG/ML INTRATHECAL 40 ML; MORPHINE SULFATE, P.F. 11.5MG/ML INTRATHECAL 35 ML; MORPHINE SULFATE, P.F. 1MG/ML INJECTABLE 250 ML; MORPHINE SULFATE, P.F. 25MG/ML INTRATHECAL 30 ML; MORPHINE SULFATE, P.F. 30MG/ML INTRATHECAL 18 ML; MORPHINE SULFATE, P.F. 33MG/ML INTRATHECAL 30 ML; MORPHINE SULFATE, P.F. 35MG/ML INTRATHECAL 35 ML; MORPHINE SULFATE, P.F. 40MG/ML INTRATHECAL 18 ML 20 ML 35 ML; MORPHINE SULFATE, P.F. 42MG/ML INTRATHECAL 35 ML; MORPHINE SULFATE, P.F. 50MG/ML INTRATHECAL 18 ML 40 ML; MORPHINE SULFATE, P.F. 5MG/ML INTRATHECAL 40 ML; MORPHINE SULFATE/BACLOFEN P.F. 25MG/1500MCG/ML INTRATHECAL 18 ML (28 DIFFERENT PRODUCTS) Rx #'s:N0396046 N0397450 N0404861 N0404320 N0389241 N0398238 N0408869 N0396836 N0390297 N0393345 N0393647 N0395395 N0397377 N0400800 N0403100 N0405536 N0408890 N0390024 N0391848 N0398239 N0403727 N0386864 N0388540 N0391192 N0391588 N0391831 N0391832 N0395396 N0396449 N0403824 N0403830 N0405260 N0405432 N0406253 N0407952 N0408884 N0393648 N0408194 N0394358 N0397366 N0397367 N0398708 N0398710 N0399636 N0400170 N0403098 N0405257 N0391608 N0401173 N0403253 N0405115 N0406436 N0390298 N0395170 N0407252 N0407520 N0392176 N0399300 N0406567 N0407428 N0387601 N0401757 N0388225 N0388588 N0392887 N0395240 N0398236 N0400870 N0404729 N0408213 N0399681 N0394427 N0388559 N0402004 N0386844 N0406159 N0390186 N0396640 N0404315 N0388587 N0402386 N0409165 N0389663 N0392048 N0387598 N0395522 N0396441 N0403779 N0405538 N0406915 N0399871 N0407182 Class II Lack of Assurance of Sterility: Franck's Lab Inc. initiated a recall of all Sterile Human Drugs distributed between 11/21/2011 and 05/21/2012. FDA environmental sampling revealed the presence of microorganisms and fungal growth in the clean room where sterile products were prepared. Franck's Lab Inc., d.b.a. Franck's Compounding Lab
Drugs MOXIFLOXACIN 150MCG/0.1ML (1.5MG/ML) INJECTABLE 10 ML 20 ML (2 DIFFERENT PRODUCTS) Rx #'s: 0384231 0384231 Class II Lack of Assurance of Sterility: Franck's Lab Inc. initiated a recall of all Sterile Human Drugs distributed between 11/21/2011 and 05/21/2012. FDA environmental sampling revealed the presence of microorganisms and fungal growth in the clean room where sterile products were prepared. Franck's Lab Inc., d.b.a. Franck's Compounding Lab
Drugs NADH-FFC 10 MG/CC INJECTABLE 10 ML (1 PRODUCT) Rx #: 0390500 Class II Lack of Assurance of Sterility: Franck's Lab Inc. initiated a recall of all Sterile Human Drugs distributed between 11/21/2011 and 05/21/2012. FDA environmental sampling revealed the presence of microorganisms and fungal growth in the clean room where sterile products were prepared. Franck's Lab Inc., d.b.a. Franck's Compounding Lab
Drugs NANDROLONE DECANOATE (H) 200MG/ML INJECTABLE 1 ML 5 ML 6 ML; NANDROLONE DECANOATE 100MG/ML INJECTABLE 5 ML; NANDROLONE DECANOATE 300MG/ML INJECTABLE 10 ML 30 ML (6 DIFFERENT PRODUCTS) Rx #'s: C0371167 C0371185 C0371187 C0371193 C0381331 C0381336 C0381348 C0381353 C0381360 C0381364 C0381366 C0381371 C0384632 C0384634 C0384637 C0389199 C0389200 C0389201 C0389205 C0389216 C0389219 C0389223 C0389224 C0392398 C0392399 C0392401 C0392405 C0392407 C0392409 C0392410 C0392411 C0392412 C0392414 C0392418 C0392419 C0392421 C0392426 C0392429 C0392433 C0392434 C0392435 C0392436 C0392438 C0392441 C0394169 C0394170 C0394171 C0394172 C0394173 C0394174 C0394175 C0394176 C0394177 C0394178 C0394179 C0394180 C0396357 C0396362 C0396365 C0396370 C0396374 C0396377 C0396388 C0396397 C0396398 C0397477 C0397478 C0397479 C0397481 C0397482 C0397484 C0397486 C0397487 C0397488 C0397489 C0397491 C0397492 C0397493 C0397494 C0397495 C0397496 C0397497 C0397498 C0397500 C0397501 C0397502 C0400024 C0400033 C0400034 C0400035 C0400036 C0400037 C0400038 C0400039 C0400040 C0400041 C0400218 C0400219 C0400221 C0400223 C0400224 C0400225 C0400226 C0400230 C0400231 C0400232 C0400233 C0400236 C0400237 C0400238 C0400239 C0400240 C0400242 C0400243 C0402690 C0402700 C0402701 C0402704 C0402705 C0402708 C0402717 C0402719 C0402721 C0402723 C0402724 C0402727 C0402731 C0402734 C0406972 C0371720 C0395592 C0405074 C0405076 C0405101 C0405103 C0405108 C0405114 C0407649 C0407651 C0407653 C0407654 C0391968 C0403337 C0401434 C0401434 Class II Lack of Assurance of Sterility: Franck's Lab Inc. initiated a recall of all Sterile Human Drugs distributed between 11/21/2011 and 05/21/2012. FDA environmental sampling revealed the presence of microorganisms and fungal growth in the clean room where sterile products were prepared. Franck's Lab Inc., d.b.a. Franck's Compounding Lab
Drugs ONDANSETRON HCL, MDV 2MG/ML (40MG/20ML) INJECTABLE 200 ML 40 ML 400 ML 48 ML 600 ML 800 ML; ONDANSETRON HCL, P.F. 2MG/ML (4MG/2ML) INJECTABLE 20 ML 200 ML 24 ML 40 ML 48 ML (11 DIFFERENT PRODUCTS) Rx #'s: 0403973 0408102 0403973 0409770 0403973 0403973 0400158 0400507 0400959 0402186 0398525 0400507 0400959 0398520 0400995 0400997 Class II Lack of Assurance of Sterility: Franck's Lab Inc. initiated a recall of all Sterile Human Drugs distributed between 11/21/2011 and 05/21/2012. FDA environmental sampling revealed the presence of microorganisms and fungal growth in the clean room where sterile products were prepared. Franck's Lab Inc., d.b.a. Franck's Compounding Lab
Drugs PACLITAXEL 6MG/ML INJECTABLE 500 ML (1 PRODUCT) Rx #'s: 0379143 0379249 Class II Lack of Assurance of Sterility: Franck's Lab Inc. initiated a recall of all Sterile Human Drugs distributed between 11/21/2011 and 05/21/2012. FDA environmental sampling revealed the presence of microorganisms and fungal growth in the clean room where sterile products were prepared. Franck's Lab Inc., d.b.a. Franck's Compounding Lab
Drugs PANTOTHENIC ACID 1MG/ML INJECTABLE 30 ML (1 PRODUCT) Rx #: 0401630 Class II Lack of Assurance of Sterility: Franck's Lab Inc. initiated a recall of all Sterile Human Drugs distributed between 11/21/2011 and 05/21/2012. FDA environmental sampling revealed the presence of microorganisms and fungal growth in the clean room where sterile products were prepared. Franck's Lab Inc., d.b.a. Franck's Compounding Lab
Drugs PAPAVERINE/ALPROSTADIL 30MG/10MCG/ML INJECTABLE 10 ML; PAPAVERINE/ALPROSTADIL 30MG/15MCG/ML INJECTABLE 10 ML (2 DIFFERENT PRODUCTS) Rx #'s: 0406632 0390375 Class II Lack of Assurance of Sterility: Franck's Lab Inc. initiated a recall of all Sterile Human Drugs distributed between 11/21/2011 and 05/21/2012. FDA environmental sampling revealed the presence of microorganisms and fungal growth in the clean room where sterile products were prepared. Franck's Lab Inc., d.b.a. Franck's Compounding Lab
Drugs PAPAVERINE/PHENTOLAMINE/ATROPINE NS 3.6MG/0.4MG/0.04MG INJECTABLE 13 ML (1 PRODUCT) Rx #: 0394926 Class II Lack of Assurance of Sterility: Franck's Lab Inc. initiated a recall of all Sterile Human Drugs distributed between 11/21/2011 and 05/21/2012. FDA environmental sampling revealed the presence of microorganisms and fungal growth in the clean room where sterile products were prepared. Franck's Lab Inc., d.b.a. Franck's Compounding Lab
Drugs PENICILLIN G POTASSIUM 10,000U/ML INJECTABLE 1 ML (1 PRODUCT) Rx #'s: 0390477 0400314 Class II Lack of Assurance of Sterility: Franck's Lab Inc. initiated a recall of all Sterile Human Drugs distributed between 11/21/2011 and 05/21/2012. FDA environmental sampling revealed the presence of microorganisms and fungal growth in the clean room where sterile products were prepared. Franck's Lab Inc., d.b.a. Franck's Compounding Lab
Drugs PHENTOLAMINE 10MG/ML INJECTABLE 6 ML; PHENTOLAMINE 1MG/ML INJECTABLE 2 ML 5 ML; PHENTOLAMINE 5MG/ML INJECTABLE 20 ML 50 ML (5 DIFFERENT PRODUCTS) Rx #'s: 0362307 0404196 0395753 0395753 0388923 0364468 Class II Lack of Assurance of Sterility: Franck's Lab Inc. initiated a recall of all Sterile Human Drugs distributed between 11/21/2011 and 05/21/2012. FDA environmental sampling revealed the presence of microorganisms and fungal growth in the clean room where sterile products were prepared. Franck's Lab Inc., d.b.a. Franck's Compounding Lab
Drugs PHENYLEPH/DICLOF/TROPIC/PROPARAC/POVIDONE IODINE SOL. 10%/0.1%/1%/0.5%/5% OPHTHA 10 ML 2 ML 20 ML 3 ML (4 DIFFERENT PRODUCTS) Rx #'s: 0381590 0384915 0381590 0384915 Class II Lack of Assurance of Sterility: Franck's Lab Inc. initiated a recall of all Sterile Human Drugs distributed between 11/21/2011 and 05/21/2012. FDA environmental sampling revealed the presence of microorganisms and fungal growth in the clean room where sterile products were prepared. Franck's Lab Inc., d.b.a. Franck's Compounding Lab
Drugs PHENYLEPHRINE HCL IN BSS - P.F. OPHTHALMIC 1% INJECTABLE 35 ML; PHENYLEPHRINE HCL, 1ML VIAL*** 1% (10MG/ML) INJECTABLE 1 ML 10 ML 25 ML 5 ML 50 ML; PHENYLEPHRINE, STSL, P.F. (0.5ML SYRINGE, SLIP-TIP, NO NEEDLE) 1.25% INJECTABLE 5 ML 7.5 ML (8 DIFFERENT PRODUCTS) Rx #'s: 0407245 0405512 0390573 0401816 0391676 0392234 0388024 0405512 0391676 0362742 0362742 Class II Lack of Assurance of Sterility: Franck's Lab Inc. initiated a recall of all Sterile Human Drugs distributed between 11/21/2011 and 05/21/2012. FDA environmental sampling revealed the presence of microorganisms and fungal growth in the clean room where sterile products were prepared. Franck's Lab Inc., d.b.a. Franck's Compounding Lab
Drugs PHENYLEPHRINE/TROPICAMIDE (P.F.) SOLUTION 2.5%/1% OPHTHALMIC 5 ML (1 PRODUCT) Rx #: 0401908 Class II Lack of Assurance of Sterility: Franck's Lab Inc. initiated a recall of all Sterile Human Drugs distributed between 11/21/2011 and 05/21/2012. FDA environmental sampling revealed the presence of microorganisms and fungal growth in the clean room where sterile products were prepared. Franck's Lab Inc., d.b.a. Franck's Compounding Lab
Drugs PHENYLEPHRINE/TROPICAMIDE/PROPARACAINE SOLUTION 2.5%/1%/0.5% OPHTHALMIC 120 ML 25 ML 30 ML 5 ML 90 ML (5 DIFFERENT PRODUCTS) Rx #'s: 0392909 0392909 0392909 0387234 0392909 Class II Lack of Assurance of Sterility: Franck's Lab Inc. initiated a recall of all Sterile Human Drugs distributed between 11/21/2011 and 05/21/2012. FDA environmental sampling revealed the presence of microorganisms and fungal growth in the clean room where sterile products were prepared. Franck's Lab Inc., d.b.a. Franck's Compounding Lab
Drugs PILOCARPINE HCL P.F IN B.S.S OPHTHALMIC 1% INJECTABLE 36 ML; PILOCARPINE HCL SOLUTION 0.5% OPHTHALMIC 30 ML; PILOCARPINE HCL SOLUTION (PF) 0.5% OPHTHALMIC 30 ML (3 DIFFERENT PRODUCTS) Rx #'s: 0407246 0365303 0387896 Class II Lack of Assurance of Sterility: Franck's Lab Inc. initiated a recall of all Sterile Human Drugs distributed between 11/21/2011 and 05/21/2012. FDA environmental sampling revealed the presence of microorganisms and fungal growth in the clean room where sterile products were prepared. Franck's Lab Inc., d.b.a. Franck's Compounding Lab
Drugs POVIDONE-IODINE OPHTHALMIC 5% SOLUTION 10 ML 125 ML 15 ML 40 ML 50 ML; POVIDONE-IODINE, BUFFERED IN BSS 4.6% OPHTHALMIC 100 ML 120 ML 200 ML (8 DIFFERENT PRODUCTS) Rx #'s: 0387489 0387820 0401069 0393386 0387489 0387489 0374184 0374184 0374184 Class II Lack of Assurance of Sterility: Franck's Lab Inc. initiated a recall of all Sterile Human Drugs distributed between 11/21/2011 and 05/21/2012. FDA environmental sampling revealed the presence of microorganisms and fungal growth in the clean room where sterile products were prepared. Franck's Lab Inc., d.b.a. Franck's Compounding Lab
Drugs POVIDONE-IODINE/LIDOCAINE/TETRACAINE 4.6%/4%/0.5% OPHTHALMIC 30 ML (1 PRODUCT) Rx #: 0410218 Class II Lack of Assurance of Sterility: Franck's Lab Inc. initiated a recall of all Sterile Human Drugs distributed between 11/21/2011 and 05/21/2012. FDA environmental sampling revealed the presence of microorganisms and fungal growth in the clean room where sterile products were prepared. Franck's Lab Inc., d.b.a. Franck's Compounding Lab
Drugs PREDNISOLONE ACETATE 10MG/ML INJECTABLE 10 MLS (1 PRODUCT) Rx #: 0404272 Class II Lack of Assurance of Sterility: Franck's Lab Inc. initiated a recall of all Sterile Human Drugs distributed between 11/21/2011 and 05/21/2012. FDA environmental sampling revealed the presence of microorganisms and fungal growth in the clean room where sterile products were prepared. Franck's Lab Inc., d.b.a. Franck's Compounding Lab
Drugs PROCAINE HCL, P.F. 1% INJECTABLE 1000 ML 180 ML; PROCAINE HCL, P.F. 2% INJECTABLE 300 ML 360 ML 450 ML; PROCAINE HCL, P.F. 8% INJECTABLE 20 ML 60 ML (7 DIFFERENT PRODUCTS) Rx #'s: 0396686 0404360 0390749 0401266 0401266 0390749 0387231 0404358 Class II Lack of Assurance of Sterility: Franck's Lab Inc. initiated a recall of all Sterile Human Drugs distributed between 11/21/2011 and 05/21/2012. FDA environmental sampling revealed the presence of microorganisms and fungal growth in the clean room where sterile products were prepared. Franck's Lab Inc., d.b.a. Franck's Compounding Lab
Drugs PROGESTERONE AQUEOUS 2MG/ML INJECTABLE 3 ML; PROGESTERONE IN COTTONSEED OIL 50MG/ML INJECTABLE 30 ML; PROGESTERONE IN SESAME OIL 100MG/ML INJECTABLE 200 ML; PROGESTERONE IN SESAME OIL 150MG/ML INJECTABLE 1000 ML; PROGESTERONE IN SESAME OIL 50MG/ML INJECTABLE 10 MLS 30 ML (6 DIFFERENT PRODUCTS) Rx #'s: 0404389 0405327 0369106 0398391 0389137 0399520 Class II Lack of Assurance of Sterility: Franck's Lab Inc. initiated a recall of all Sterile Human Drugs distributed between 11/21/2011 and 05/21/2012. FDA environmental sampling revealed the presence of microorganisms and fungal growth in the clean room where sterile products were prepared. Franck's Lab Inc., d.b.a. Franck's Compounding Lab
Drugs PYRIDOXINE 100MG/ML INJECTABLE 150 ML 180 ML 300 ML 360 ML 450 ML (5 DIFFERENT PRODUCTS) Rx #'s: 0370793 0400021 0388933 0400021 0397238 0397238 Class II Lack of Assurance of Sterility: Franck's Lab Inc. initiated a recall of all Sterile Human Drugs distributed between 11/21/2011 and 05/21/2012. FDA environmental sampling revealed the presence of microorganisms and fungal growth in the clean room where sterile products were prepared. Franck's Lab Inc., d.b.a. Franck's Compounding Lab
Drugs QUADMIX 12MG/1MG/10MCG/150MCG/ML INJECTABLE 10 ML; QUADMIX 15MG/0.5MG/5MCG/100MCG/ML INJECTABLE 10 ML; QUADMIX 30MG/0.5MG/5MCG/100MCG/ML INJECTABLE 10 ML; QUADMIX 30MG/1MG/10MCG/100MCG/ML INJECTABLE 1 ML 10 ML 2 ML 30 ML 5 ML; QUADMIX 30MG/1MG/20MCG/100MCG/ML INJECTABLE 10 ML 10 MLS 5 ML; QUADMIX 30MG/1MG/40MCG/100MCG/ML INJECTABLE 10 ML; QUADMIX 30MG/2MG/20MCG/100MCG/ML INJECTABLE 10 ML 2 ML 4 ML; QUADMIX 30MG/2MG/40MCG/100MCG/ML INJECTABLE 10 ML 15 ML; QUADMIX 30MG/2MG/60MCG/100MCG/ML INJECTABLE 5 ML; QUADMIX 30MG/3MG/50MCG/100MCG/ML INJECTABLE 10 ML 2.5 ML; QUADMIX 30MG/4MG/60MCG/100MCG/ML INJECTABLE 5 ML; QUADMIX 30MG/6MG/60MCG/100MCG/ML INJECTABLE 5 ML (22 DIFFERENT PRODUCTS) Rx #'s: 0398154 0361427 0394539 0398379 0398383 0398654 0401481 0354901 0358554 0362399 0364565 0365677 0374214 0378140 0387717 0387828 0388410 0388613 0389582 0389605 0389831 0389995 0391836 0392132 0392791 0395761 0395780 0398565 0399139 0399236 0402039 0402348 0402913 0404655 0404956 0407300 0407826 0407886 0409193 0409392 0381541 0381541 0374200 0388333 0389328 0389995 0400261 0400734 0401275 0408300 0369037 0399507 0393432 0400721 0376498 0398517 0405296 0382422 0383030 0387924 0388078 0389173 0389292 0389398 0392540 0396157 0396195 0396743 0401143 0408802 0362184 0403309 0362184 0358883 0388846 0392210 0399742 0397435 0378334 0380750 0370502 0404839 0355136 0375023 0406832 Class II Lack of Assurance of Sterility: Franck's Lab Inc. initiated a recall of all Sterile Human Drugs distributed between 11/21/2011 and 05/21/2012. FDA environmental sampling revealed the presence of microorganisms and fungal growth in the clean room where sterile products were prepared. Franck's Lab Inc., d.b.a. Franck's Compounding Lab
Drugs RANIBIZUMAB, SDPF - (0.05ML SYRINGE, 31G, 5/16") 10MG/ML INJECTABLE 1 ML 1.25 ML 1.75 ML 2.3 ML 2.35 ML 20 ML 20.15 ML 20.45 ML 20.6 ML 20.9 ML 21.05 ML 21.2 ML 21.25 ML 21.45 ML 21.6 ML 21.7 ML 24.4 ML 28.1 ML (18 DIFFERENT PRODUCTS) Rx #'s: 0397570 0397570 0397570 0397570 0397570 0373846 0373846 0373846 0373846 0373846 0373846 0373846 0373846 0373846 0373846 0373846 0373846 0373846 Class II Lack of Assurance of Sterility: Franck's Lab Inc. initiated a recall of all Sterile Human Drugs distributed between 11/21/2011 and 05/21/2012. FDA environmental sampling revealed the presence of microorganisms and fungal growth in the clean room where sterile products were prepared. Franck's Lab Inc., d.b.a. Franck's Compounding Lab
Drugs RANITIDINE 25MG/ML INJECTABLE 200 ML 480 ML 800 ML (3 DIFFERENT PRODUCTS) Rx #'s: 0398569 0399778 0398076 Class II Lack of Assurance of Sterility: Franck's Lab Inc. initiated a recall of all Sterile Human Drugs distributed between 11/21/2011 and 05/21/2012. FDA environmental sampling revealed the presence of microorganisms and fungal growth in the clean room where sterile products were prepared. Franck's Lab Inc., d.b.a. Franck's Compounding Lab
Drugs RIBOFLAVIN SOLUTION 0.1% OPHTHALMIC 10 ML 5 ML; RIBOFLAVIN SOLUTION, P.F. 0.1% OPHTHALMIC 90 ML (3 DIFFERENT PRODUCTS) Rx #'s: 0400853 0400853 0386510 Class II Lack of Assurance of Sterility: Franck's Lab Inc. initiated a recall of all Sterile Human Drugs distributed between 11/21/2011 and 05/21/2012. FDA environmental sampling revealed the presence of microorganisms and fungal growth in the clean room where sterile products were prepared. Franck's Lab Inc., d.b.a. Franck's Compounding Lab
Drugs RUBIDIUM 200MCG/ML INJECTABLE 30 ML (1 PRODUCT) Rx #: 0398938 Class II Lack of Assurance of Sterility: Franck's Lab Inc. initiated a recall of all Sterile Human Drugs distributed between 11/21/2011 and 05/21/2012. FDA environmental sampling revealed the presence of microorganisms and fungal growth in the clean room where sterile products were prepared. Franck's Lab Inc., d.b.a. Franck's Compounding Lab
Drugs SELENIUM 200MCG/ML INJECTABLE 150 ML 30 ML 60 ML (3 DIFFERENT PRODUCTS) Rx #'s: 0370786 0374590 0369109 0374590 Class II Lack of Assurance of Sterility: Franck's Lab Inc. initiated a recall of all Sterile Human Drugs distributed between 11/21/2011 and 05/21/2012. FDA environmental sampling revealed the presence of microorganisms and fungal growth in the clean room where sterile products were prepared. Franck's Lab Inc., d.b.a. Franck's Compounding Lab
Drugs SERMORELIN ACETATE, LYOPHILIZED 6MG KIT 1 KIT 2 KIT; SERMORELIN ACETATE, LYOPHILIZED 6MG VIAL 2 VIAL; SERMORELIN ACETATE, LYOPHILIZED 9MG KIT 1 KIT 3 KIT 6 KIT; SERMORELIN ACETATE, LYOPHILIZED 9MG VIAL 1 VIAL 2 VIAL 3 VIAL 30 VIAL; SERMORELIN ACETATE/GHRP 2,6 - LYOPHILIZED 9MG/3.15MG/3.15MG KIT 1 KIT 3 KIT; SERMORELIN ACETATE/GHRP 2,6 - LYOPHILIZED 9MG/3.15MG/3.15MG VIAL 1 VIAL 3 VIAL 4 VIAL 7 VIAL (16 DIFFERENT PRODUCTS) Rx #'s: 0386512 0388165 0390153 0392066 0392315 0392317 0384766 0392082 0392094 0379483 0385383 0393729 0397989 0398600 0406470 0407865 0407875 0409041 0410198 0386262 0399600 0386262 0408795 0395274 0395279 0395285 0376062 0389403 0399790 0400511 0400527 0401472 0402407 0402536 0403638 0406466 0406692 0407272 0405789 0394350 0402541 0394350 0392062 0392062 Class II Lack of Assurance of Sterility: Franck's Lab Inc. initiated a recall of all Sterile Human Drugs distributed between 11/21/2011 and 05/21/2012. FDA environmental sampling revealed the presence of microorganisms and fungal growth in the clean room where sterile products were prepared. Franck's Lab Inc., d.b.a. Franck's Compounding Lab
Drugs SESAME OPHTHALMIC OIL 60 ML (1 PRODUCT) Rx #: 0379544 Class II Lack of Assurance of Sterility: Franck's Lab Inc. initiated a recall of all Sterile Human Drugs distributed between 11/21/2011 and 05/21/2012. FDA environmental sampling revealed the presence of microorganisms and fungal growth in the clean room where sterile products were prepared. Franck's Lab Inc., d.b.a. Franck's Compounding Lab
Drugs SODIUM BICARBONATE 4% INJECTABLE 10 ML 5 ML; SODIUM BICARBONATE 8.4% INJECTABLE 150 ML 50 ML 5000 ML; SODIUM BICARBONATE, 50ML SDV** 8.4% (1MEQ/ML) INJECTABLE 100 MLS 250 ML; SODIUM BICARBONATE, MDV 8.4% INJECTABLE 100 ML 150 ML 200 ML; SODIUM CHLORIDE 0.9% (25X10ML) INJ. SDPF **** 0.9% INJECTABLE 25 VIAL 40 ML; SODIUM CHLORIDE (STERILE) 23.4% (20MEQ/5ML) SOLUTION 1000 ML 2500 ML; SODIUM CHLORIDE 0.9% BACTERIOSTATIC ** 0.9% INJECTABLE 30 MLS 750 ML; SODIUM CHLORIDE 0.9% IRRIGATION (24X250ML)** 0.9% SOLUTION 250 ML; SODIUM CHLORIDE 0.9%, 100ML I.V. BAG** 0.9% INJECTABLE 100 ML; SODIUM TETRADECYL SO4 3% INJECTABLE 20 ML; SODIUM TETRADECYL SULFATE 0.2 % INJECTABLE 30 ML (20 DIFFERENT PRODUCTS) Rx #'s: 0395804 0395804 0404876 0405488 0404876 0403179 0403991 0407590 0407590 0394748 0394749 0403382 0405156 0401795 0401795 0400457 0400944 0392902 0406332 0398643 0405500 0397467 Class II Lack of Assurance of Sterility: Franck's Lab Inc. initiated a recall of all Sterile Human Drugs distributed between 11/21/2011 and 05/21/2012. FDA environmental sampling revealed the presence of microorganisms and fungal growth in the clean room where sterile products were prepared. Franck's Lab Inc., d.b.a. Franck's Compounding Lab
Drugs STRONTIUM 1 MG/ML INJECTABLE 30 ML 60 ML (2 DIFFERENT PRODUCTS) Rx #'s: 0374732 0374732 Class II Lack of Assurance of Sterility: Franck's Lab Inc. initiated a recall of all Sterile Human Drugs distributed between 11/21/2011 and 05/21/2012. FDA environmental sampling revealed the presence of microorganisms and fungal growth in the clean room where sterile products were prepared. Franck's Lab Inc., d.b.a. Franck's Compounding Lab
Drugs TAURINE 50MG/ML INJECTABLE 120 ML 30 ML 40 ML 60 ML (4 DIFFERENT PRODUCTS) Rx #'s: 0374591 0374591 0391633 0391633 0374591 Class II Lack of Assurance of Sterility: Franck's Lab Inc. initiated a recall of all Sterile Human Drugs distributed between 11/21/2011 and 05/21/2012. FDA environmental sampling revealed the presence of microorganisms and fungal growth in the clean room where sterile products were prepared. Franck's Lab Inc., d.b.a. Franck's Compounding Lab
Drugs TESTOSTERONE CYP/ESTRADIOL CYP 50MG/2MG/ML INJECTABLE 5 ML; TESTOSTERONE CYPIONATE 50MG/ML INJECTABLE 12 ML 2.5 ML (4 DIFFERENT PRODUCTS) 5 ML; TESTOSTERONE PROPIONATE 200MG/ML INJECTABLE 10 ML Rx #'s:C0397709 C0403979 C0387544 C0387581 C0387806 C0388157 C0395001 C0397028 C0397915 C0400555 C0400709 C0404008 C0405234 C0390252 C0391731 C0393592 C0406126 Class II Lack of Assurance of Sterility: Franck's Lab Inc. initiated a recall of all Sterile Human Drugs distributed between 11/21/2011 and 05/21/2012. FDA environmental sampling revealed the presence of microorganisms and fungal growth in the clean room where sterile products were prepared. Franck's Lab Inc., d.b.a. Franck's Compounding Lab
Drugs TETRACAINE HCL OPHTHALMIC 0.05% SOLUTION 3 ML 6 ML; TETRACAINE HCL P.F. OPHTHALMIC 0.5% SOLUTION 30 ML (3 DIFFERENT PRODUCTS) Rx #'s: 0387030 0388227 0388955 0389127 0389637 0389994 0391604 0391610 0394004 0394519 0394522 0396467 0396470 0397420 0397616 0399672 0400482 0401216 0401503 0402138 0403400 0403543 0404150 0405978 0362094 0382304 Class II Lack of Assurance of Sterility: Franck's Lab Inc. initiated a recall of all Sterile Human Drugs distributed between 11/21/2011 and 05/21/2012. FDA environmental sampling revealed the presence of microorganisms and fungal growth in the clean room where sterile products were prepared. Franck's Lab Inc., d.b.a. Franck's Compounding Lab
Drugs TETRACOSACTIDE ACETATE (COSYNTROPIN) 0.25MG/ML INJECTABLE 1 ML (1 PRODUCT) Rx #'s: 0387998 0391766 0398634 0400173 0400383 0402841 Class II Lack of Assurance of Sterility: Franck's Lab Inc. initiated a recall of all Sterile Human Drugs distributed between 11/21/2011 and 05/21/2012. FDA environmental sampling revealed the presence of microorganisms and fungal growth in the clean room where sterile products were prepared. Franck's Lab Inc., d.b.a. Franck's Compounding Lab
Drugs THIAMINE HCL 100MG/ML INJECTABLE 300 ML 360 ML 450 ML (3 DIFFERENT PRODUCTS) Rx #'s: 0384580 0384580 0384580 Class II Lack of Assurance of Sterility: Franck's Lab Inc. initiated a recall of all Sterile Human Drugs distributed between 11/21/2011 and 05/21/2012. FDA environmental sampling revealed the presence of microorganisms and fungal growth in the clean room where sterile products were prepared. Franck's Lab Inc., d.b.a. Franck's Compounding Lab
Drugs THIOTEPA, LYOPHILIZED 15MG INJECTABLE 8 VIAL; THIOTEPA, LYOPHILIZED 30MG INJECTABLE 4 VIAL 8 VIAL; THIOTEPA, LYOPHILIZED 60MG INJECTABLE 2 VIAL (4 DIFFERENT PRODUCTS) Rx #'s: 0391709 0393510 0390995 0374399 0393816 Class II Lack of Assurance of Sterility: Franck's Lab Inc. initiated a recall of all Sterile Human Drugs distributed between 11/21/2011 and 05/21/2012. FDA environmental sampling revealed the presence of microorganisms and fungal growth in the clean room where sterile products were prepared. Franck's Lab Inc., d.b.a. Franck's Compounding Lab
Drugs TOBRAMYCIN 1.4% (14MG/ML) OPHTHALMIC 15 ML 3 ML 7 ML; TOBRAMYCIN SOLUTION** 0.3% OPHTHALMIC 30 MLS 5 MLS; TOBRAMYCIN SULFATE** (25X2ML) 80MG/2ML INJECTABLE 100 ML 150 ML 50 MLS; TOBRAMYCIN/AMPHOTERICIN-B/BUDESONIDE, STERILE 125MG/5MG/0.6MG/5ML NASO-NEB 70 ML (9 DIFFERENT PRODUCTS) Rx #'s: 0398243 0394272 0383374 0396251 0365041 0409704 0406772 0406773 0399065 0384313 Class II Lack of Assurance of Sterility: Franck's Lab Inc. initiated a recall of all Sterile Human Drugs distributed between 11/21/2011 and 05/21/2012. FDA environmental sampling revealed the presence of microorganisms and fungal growth in the clean room where sterile products were prepared. Franck's Lab Inc., d.b.a. Franck's Compounding Lab
Drugs TRIAMCINOLONE ACETONIDE 4MG/ML (0.4MG/0.1ML) INJECTABLE 10 ML 5 ML TRIAMCINOLONE ACETONIDE (T), STSL (0.025ML SYRINGE, 30G, 1/2") 40MG/ML (4MG/0.1M 0.075 SYR 0.1 SYR TRIAMCINOLONE ACETONIDE 0.25ML SYRINGE (T) 40MG/ML (4MG/0.1ML) OPHTHALMIC 0.25 ML 0.5 ML TRIAMCINOLONE ACETONIDE 20MG/ML INJECTABLE 1 ML TRIAMCINOLONE ACETONIDE 80MG/ML INJECTABLE 100 ML TRIAMCINOLONE ACETONIDE IN VITREOUS VEHICLE, P.F. 10MG/ML (1MG/0.1ML) OPHTHALMIC 0.1 ML 50 ML TRIAMCINOLONE ACETONIDE IN VITREOUS VEHICLE, P.F. 20MG/ML (2MG/0.1ML) OPHTHALMIC 0.1 ML 0.2 ML TRIAMCINOLONE ACETONIDE IN VITREOUS VEHICLE, P.F. 40MG/ML (4MG/0.1ML) OPHTHALMIC 0.05 ML 0.1 ML 0.15 ML 0.2 ML 0.25 ML 0.5 ML 0.6 ML 0.75 ML 0.8 ML 0.9 ML 1 ML 1.2 ML 1.25 ML 10 ML 14 ML 2 ML 2.5 ML 3 ML 30 ML 360 ML 4 ML 5 ML 6 ML 8 ML TRIAMCINOLONE ACETONIDE IN VITREOUS VEHICLE, P.F. 80MG/ML (8MG/0.1ML) OPHTHALMIC 0.25 ML 0.3 ML 0.5 ML 0.75 ML 2 ML TRIAMCINOLONE ACETONIDE P.F. (OPHTHALMIC) 40MG/ML (4MG/0.1ML) OPHTHALMIC 1 ML 10 ML TRIAMCINOLONE ACETONIDE, P.F. 80MG/ML INJECTABLE 150 ML 75 ML TRIAMCINOLONE DIACETATE 40MG/ML INJECTABLE 3 ML 4 ML TRIAMCINOLONE DIACETATE, PRESERVATIVE FREE 40MG/ML INJECTABLE 360 ML (48 DIFFERENT PRODUCTS) Rx #'s: 0387290 0387290 0400922 0405419 0362272 0362272 0392196 0392211 0389062 0402046 0366190 0376388 0377225 0363673 0355420 0394877 0359658 0361833 0376569 0390305 0394394 0394710 0397895 0399493 0402872 0403787 0394877 0365100 0390365 0391344 0391346 0391866 0405531 0355420 0399719 0365828 0394562 0380506 0406925 0398935 0387737 0387737 0401220 0404375 0387737 0395444 0398847 0360739 0365769 0365769 0404497 0407975 0408999 0351511 0398847 0361324 0403770 0410188 0405655 0365764 0403770 0406991 0365769 0403770 0407885 0403574 0403577 0404165 0403579 0392063 0400699 0397870 0397870 0402420 0402420 0406941 Class II Lack of Assurance of Sterility: Franck's Lab Inc. initiated a recall of all Sterile Human Drugs distributed between 11/21/2011 and 05/21/2012. FDA environmental sampling revealed the presence of microorganisms and fungal growth in the clean room where sterile products were prepared. Franck's Lab Inc., d.b.a. Franck's Compounding Lab
Drugs TRIMIX 9MG / 0.3MG /3.3MCG INJECTABLE 6 ML; TRIMIX 9MG / 0.3MG /6.6MCG INJECTABLE 6 ML; TRIMIX 9MG / 1MG / 10MCG INJECTABLE 10 ML; TRIMIX ((LYOPHILIZED)) - 2ML VIAL 30MG / 1MG / 10MCG INJECTABLE 10 ML 10 VIALS 2 ML 4 ML 50 ML; TRIMIX ((LYOPHILIZED)) - 5ML VIAL 30MG / 2MG / 20MCG INJECTABLE 10 ML; TRIMIX ((LYOPHILIZED)) - 5ML VIAL 30MG / 2MG / 40MCG INJECTABLE 100 ML 5 ML 75 ML; TRIMIX 10MG / 0.5MG / 1MCG INJECTABLE 10 ML; TRIMIX 10MG / 1MG / 5MCG INJECTABLE 10 ML; TRIMIX 10MG/1MG/0.5MCG INJECTABLE 10 ML; TRIMIX 12.5MG/0.83MG/8.33MCG INJECTABLE 10 ML; TRIMIX 12MG / 1MG / 12MCG INJECTABLE 10 ML; TRIMIX 12MG / 1MG / 9MCG INJECTABLE 10 ML 10 MLS 20 ML 30 ML 5 ML; TRIMIX 12MG/1MG/5MCG INJECTABLE 10 ML; TRIMIX 15MG / 1MG / 10MCG INJECTABLE 3 ML 5 ML; TRIMIX 22.5MG/0.83MG/3MCG INJECTABLE 10 ML; TRIMIX 22.5MG/0.83MG/8.33MCG INJECTABLE 1 ML 10 ML 15 ML 2.5 ML 3 ML 30 ML 5 ML; TRIMIX 24MG / 1MG / 10MCG INJECTABLE 10 ML; TRIMIX 24MG / 1MG / 18MCG INJECTABLE 10 ML; TRIMIX 25MG/ 1MG / 10MCG INJECTABLE 10 ML; TRIMIX 28MG / 0.9MG / 37MCG INJECTABLE 5 ML; TRIMIX 30MG / 0.1MG / 40MCG INJECTABLE 10 ML; TRIMIX 30MG / 0.2MG / 10MCG INJECTABLE 10 ML; TRIMIX 30MG / 0.5MG / 10MCG INJECTABLE 10 ML; 120 ML 5 ML 60 MLS; TRIMIX 30MG / 0.5MG / 20MCG INJECTABLE 1.7 ML 10 ML 50 ML; TRIMIX 30MG / 0.5MG / 50MCG/ML INJECTABLE 10 ML; TRIMIX 30MG / 0.5MG / 5MCG INJECTABLE 10 ML 5 ML; TRIMIX 30MG / 10MG / 20MCG INJECTABLE 5 ML; TRIMIX 30MG / 10MG / 60MCG INJECTABLE 10 ML 10 MLS 20 ML 5 ML; TRIMIX 30MG / 1MG / 18MCG INJECTABLE 5 ML; TRIMIX 30MG / 1MG / 2.5MCG INJECTABLE 3 ML 5 ML; TRIMIX 30MG / 1MG / 20MCG INJECTABLE 1 ML 10 ML 10 MLS 3 ML 5 ML; TRIMIX 30MG / 1MG / 30MCG INJECTABLE 10 ML 5 ML; TRIMIX 30MG / 1MG / 40MCG INJECTABLE 10 ML; TRIMIX 30MG / 1MG / 50MCG INJECTABLE 10 ML 10 MLS 100 ML 5 ML; TRIMIX 30MG / 1MG / 5MCG INJECTABLE 10 ML 20 ML 5 ML; TRIMIX 30MG / 2MG / 100MCG INJECTABLE 20 ML; TRIMIX 30MG / 2MG / 10MCG INJECTABLE 10 ML; TRIMIX 30MG / 2MG / 20MCG INJECTABLE 1 ML 10 ML 10 MLS 2 ML 2.5 ML 20 ML 3 ML 5 ML 5 MLS 6 ML 60 ML; TRIMIX 30MG / 2MG / 25MCG INJECTABLE 10 ML; TRIMIX 30MG / 2MG / 30MCG INJECTABLE 10 ML 10 MLS 5 ML; TRIMIX 30MG / 2MG / 3MCG INJECTABLE 5 ML; TRIMIX 30MG / 2MG / 40MCG INJECTABLE 1 ML 1.25 ML 10 ML 15 ML 2 ML 2.5 ML 20 ML 20 MLS 30 ML 4 ML 40 ML 5 ML 6 ML 60 ML; TRIMIX 30MG / 4MG / 3.5MCG INJECTABLE 10 ML; TRIMIX 30MG / 4MG / 2.5MCG INJECTABLE 10 ML 2 ML 5 ML; TRIMIX 30MG / 4MG / 20MCG INJECTABLE 10 ML 5 ML; TRIMIX 30MG / 4MG / 30MCG INJECTABLE 10 ML TRIMIX 30MG / 4MG / 40MCG INJECTABLE 10 ML 2 ML 2.5 ML 20 ML 5 ML; TRIMIX 30MG / 4MG / 50MCG INJECTABLE 10 ML 5 ML; TRIMIX 30MG / 4MG / 60MCG INJECTABLE 5 ML; TRIMIX 30MG / 6MG / 40MCG INJECTABLE 5 MLS; TRIMIX 7.5MG / 0.25MG / 2.5MCG INJECTABLE 10 MLS 20 MLS 5 MLS; TRIMIX (NON-STERILE POWDER) 30MG / 1MG / 10MCG INJECTABLE 30 ML 40 ML 60 ML; TRIMIX (NON-STERILE POWDER) 30MG / 2MG / 20MCG INJECTABLE 40 ML; TRIMIX (NON-STERILE POWDER) 30MG / 2MG / 40MCG INJECTABLE 200 ML 40 ML; TRIMIX (P) 30MG / 1MG / 10MCG INJECTABLE 5 ML; TRIMIX / ATROPINE 25MG/2MG/30MCG/0.08MG INJECTABLE 10 ML; TRIMIX 1.76MG / 0.58MG /5.88MCG INJECTABLE 5 ML; TRIMIX 10MG / 1MG / 50MCG INJECTABLE 10 ML; TRIMIX 12MG / 1MG / 10MCG INJECTABLE 10 ML; TRIMIX 15MG / 0.4MG / 5MCG INJECTABLE 10 ML; TRIMIX 15MG / 0.5MG / 10MCG INJECTABLE 10 ML 3 ML; TRIMIX 15MG / 0.5MG / 5MCG INJECTABLE 10 ML 5 ML; TRIMIX 15MG/5MG/2MCG/ML INJECTABLE 10 ML; TRIMIX 16.6MG / 0.55MG / 11.1MCG INJECTABLE 10 ML 20 ML 4.5 ML 5 ML; TRIMIX 16.6MG / 0.55MG / 22.2MCG INJECTABLE 10 ML 5 ML; TRIMIX 16.6MG / 0.55MG / 44.4MCG INJECTABLE 4.5 ML; TRIMIX 16.7MG / 0.56MG / 44.4MCG INJECTABLE 10 ML; TRIMIX 17.44MG / 0.64MG / 5.8MCG INJECTABLE 4.3 ML; TRIMIX 17.65MG / 0.59MG / 5.9MCG INJECTABLE 10 ML 20 ML 4.25 ML 5 ML; TRIMIX 17MG / 0.5MG / 5.88MCG INJECTABLE 5 ML; TRIMIX 17MG/0.6MG/20MCG INJECTABLE 5 ML; TRIMIX 17MG/0.6MG/5.88MCG INJECTABLE 5 ML; TRIMIX 18.9MG/0.9MG/9MCG/ML INJECTABLE 10 ML; TRIMIX 18MG / 0.6MG / 5.88MCG INJECTABLE 10 ML; TRIMIX 18MG/0.6MG/6MCG/ML INJECTABLE 4 ML 5 ML 6 ML; TRIMIX 18MG/1MG/6MCG/ML INJECTABLE 5 ML; TRIMIX 20MG / 0.5MG / 5MCG INJECTABLE 10 ML 5 ML; TRIMIX 20MG / 1MG / 40MCG INJECTABLE 10 ML; TRIMIX 20MG/1MG/30MCG/ML INJECTABLE 10 ML; TRIMIX 20MG/2MG/30MCG INJECTABLE 10 ML; TRIMIX 30MG / 1.5MG / 40MCG INJECTABLE 10 ML; TRIMIX 30MG / 1.5MG / 50MCG INJECTABLE 1 ML 3 ML; TRIMIX 30MG / 1MG / 10MCG INJECTABLE 1 ML 10 ML 10 ML 10 MLS 15 ML 2 ML 2.5 ML 20 ML 3 ML 30 ML 4 ML 40 ML 5 ML 5 MLS 50 ML; TRIMIX 30MG / 1MG / 25MCG INJECTABLE 10 ML 40 ML; TRIMIX 30MG / 2MG / 50MCG INJECTABLE 10 MLS; TRIMIX 30MG / 2MG / 60MCG INJECTABLE 10 ML 5 ML; TRIMIX 30MG / 3MG / 30MCG INJECTABLE 10 ML 5 ML; TRIMIX 30MG / 3MG / 50MCG INJECTABLE 10 ML 5 ML; TRIMIX 30MG / 3MG / 7MCG INJECTABLE 10 ML; TRIMIX 30MG / 5MG / 40MCG INJECTABLE 30 ML; TRIMIX 30MG / 5MG / 50MCG INJECTABLE 10 ML 5 ML; TRIMIX 30MG/6MG/60MCG INJECTABLE 10 ML 5 ML; TRIMIX 9MG / 0.25MG / 1.5MCG INJECTABLE 10 ML; TRIMIX STERILE 1,000MCG/0.3MG/0.1MG/0.35ML GEL 0.7 ML 1.4 ML 2.1 ML 3.5 ML; TRIMIX STERILE 1,500MCG/0.3MG/0.1MG/0.35ML GEL 2.1 ML 3.5 ML; TRIMIX STERILE 500MCG/300MCG/100MCG/0.35ML GEL 2.1 ML; TRIMIX WITH ATROPINE 18.9MG/0.9MG/9MCG/0.18MG/ML INJECTABLE 10 ML; TRIMIX WITH ATROPINE 30MG/ 1MG/ 50MCG/ 0.2MG/ML INJECTABLE 10 ML; TRIMIX, SDSM 30MG / 1MG / 10MCG INJECTABLE 10 ML; TRIMIX, SDSM 30MG / 2MG / 20MCG INJECTABLE 10 ML; TRIMIX, SDSM 30MG / 3MG / 30MCG INJECTABLE 10 ML 20 ML 5 ML; TRIMIX, SDSM 30MG / 4MG / 2.5MCG INJECTABLE 10 ML; TRIMIX, SDSM 30MG / 4MG / 40MCG INJECTABLE 10 ML 10 MLS 5 MLS; TRIMIX, SDSM 30MG / 4MG / 5MCG INJECTABLE 5 ML; TRIMIX, SDSM 30MG / 5MG / 50MCG INJECTABLE 10 ML 5 ML 5 MLS; TRIMIX, SDSM 30MG / 6MG / 60MCG INJECTABLE 10 ML 10 MLS 5 ML; TRIMIX, SDSM 30MG/6MG/30MCG INJECTABLE 10 ML (227 DIFFERENT PRODUCTS) Rx #'s: 0370964 0392699 0399999 0388807 0373823 0407907 0408836 0409758 0368890 0396425 0404388 0390568 0393084 0390568 0353060 0390096 0369563 0356202 0399491 0377731 0365263 0398599 0400417 0409104 0381235 0355859 0371377 0402545 0371377 0404586 0359139 0375269 0380498 0390885 0371652 0371652 0370384 0390476 0357298 0381009 0389478 0400908 0391406 0388541 0390476 0389352 0403385 0390300 0391406 0380532 0371606 0392256 0364156 0402994 0407589 0369206 0378697 0388874 0391939 0399751 0409764 0357230 0401215 0393374 0401252 0403616 0407339 0381249 0393047 0399227 0373040 0410204 0353362 0367634 0380616 0387463 0395032 0396526 0400059 0403263 0403268 0408301 0385463 0409902 0395126 0399133 0401102 0401107 0401651 0403704 0405197 0405760 0406316 0406322 0396285 0403691 0397249 0359198 0407962 0362367 0403023 0405308 0371668 0351463 0355946 0358970 0367278 0368955 0378244 0378494 0381048 0381893 0382831 0389390 0392285 0392879 0394905 0403994 0358379 0375331 0374070 0398377 0368154 0374011 0376715 0382454 0382831 0399423 0399645 0401306 0391641 0402714 0408696 0394497 0409808 0406673 0375182 0393832 0391683 0368348 0375182 0385666 0391426 0367299 0408918 0360740 0375301 0391074 0392376 0397160 0398142 0399608 0402052 0402492 0377170 0385187 0352706 0355092 0356255 0356732 0358621 0363754 0364595 0365070 0365619 0366077 0367690 0369330 0369413 0369770 0371950 0372657 0373473 0374074 0374392 0374730 0374749 0377455 0378324 0379558 0380891 0381211 0382037 0382046 0382986 0383709 0384705 0385187 0386830 0386838 0386841 0387525 0388003 0388219 0388610 0389400 0389613 0389902 0390005 0390119 0390361 0390416 0390575 0390590 0392011 0393375 0393527 0393802 0393821 0394721 0395123 0395253 0395362 0395619 0396264 0396704 0396920 0397032 0397650 0397679 0397931 0398131 0398331 0398696 0399673 0399676 0399926 0400329 0400747 0400874 0401081 0401356 0401580 0402139 0402289 0402383 0402504 0402543 0403355 0403486 0403789 0403798 0403802 0404070 0404189 0404775 0404793 0405117 0405387 0405403 0405643 0405872 0405918 0406134 0406144 0406252 0406389 0406712 0407038 0407237 0407380 0407464 0407479 0407941 0408051 0408630 0408801 0409019 0409021 0409137 0409248 0409681 0409745 0409918 0353075 0377170 0393821 0398665 0401094 0407571 0366685 0410242 0381447 0382347 0399747 0402383 0367834 0382756 0385041 0406641 0406741 0352749 0362161 0363543 0365973 0366062 0370030 0371579 0373491 0374377 0374749 0375400 0376274 0376650 0377613 0377756 0379507 0379766 0380749 0382500 0384286 0385041 0385187 0386025 0386153 0386315 0386401 0388556 0389501 0389584 0390924 0391308 0391593 0391721 0393171 0393193 0393470 0393669 0393752 0393993 0394102 0394158 0394780 0395464 0396003 0396807 0397514 0397845 0398082 0398120 0398157 0399466 0400076 0400747 0400994 0401283 0401391 0401852 0401983 0402284 0402611 0403016 0403414 0403797 0404866 0404898 0404908 0405390 0405420 0405999 0406556 0406569 0408171 0409272 0401125 0405089 0382347 0398891 0404891 0409279 0387983 0364714 0369832 0399010 0403415 0379074 0387649 0394705 0397102 0397315 0362465 0404557 0353244 0405761 0361584 0364611 0371055 0381231 0381963 0382957 0387867 0390079 0390103 0393067 0396875 0397590 0399060 0400458 0401399 0401840 0402783 0403198 0404246 0404367 0404421 0405259 0406450 0407058 0364670 0390408 0409519 0403276 0369241 0410377 0408734 0394080 0386949 0394080 0350278 0358363 0360732 0362193 0367614 0378564 0379488 0385896 0386949 0387277 0387639 0388526 0392373 0396939 0397133 0397688 0398684 0399909 0400497 0400949 0401212 0401399 0402230 0402905 0402941 0403622 0404180 0404404 0404717 0406327 0406592 0407801 0408526 0381963 0401820 0400295 0385464 0392330 0385464 0395215 0360252 0373883 0391666 0392924 0398059 0404946 0404947 0404229 0407881 0356445 0373904 0374588 0376266 0377187 0384452 0388865 0391973 0393277 0396844 0397399 0399233 0399919 0404386 0404475 0388356 0409496 0366411 0372326 0377187 0388932 0389124 0395764 0398549 0366732 0367231 0396533 0396813 0389134 0391530 0401532 0404513 0406403 0379750 0389313 0406696 0408045 0408330 0390919 0368313 0368712 0388796 0394361 0395060 0400660 0401494 0392545 0396348 0387490 0394867 0398714 0405315 0360540 0396750 0396751 0360540 0406192 0396749 0360539 0406191 0392161 0370736 0370760 0370761 0370762 0370800 0403632 0369880 0383841 0350689 0405502 0348975 0401621 0389916 0407178 0393099 0391195 0391858 0392812 0395340 0398698 0401134 0404651 0405304 0407231 0407978 0409571 0410034 0379343 0388182 0388441 0405300 0394920 0383835 0389118 0400140 0391821 0389184 0370948 0378725 0383648 0385151 0386543 0388519 0389803 0395964 0397239 0397773 0392692 0393785 0354435 0392692 0394743 0386063 0378224 0399544 0394366 0389119 0400435 0378196 0376272 0401773 0403650 0400095 0395637 0407732 0376926 0395747 0395105 0363547 0401747 0393444 0397194 0398504 0404949 0370047 0389069 0375921 0357844 0400956 0400956 0381262 0387267 0396029 0403164 0381589 0406317 0351335 0352279 0352654 0352887 0353030 0355228 0355437 0356233 0356461 0356528 0357100 0359134 0359766 0359829 0361123 0361309 0362924 0364728 0364793 0365086 0365454 0365964 0366546 0366812 0366922 0367357 0368219 0369038 0369989 0370277 0371095 0371128 0371218 0371788 0373059 0374079 0374240 0374369 0374696 0375104 0375808 0376148 0376825 0377068 0377917 0378152 0378531 0378578 0378820 0378879 0378938 0379715 0380902 0381458 0382659 0382718 0383637 0383799 0383938 0384023 0385436 0385662 0385834 0386301 0386406 0386822 0386826 0386972 0387046 0387267 0387614 0387617 0387704 0387760 0387802 0387883 0387901 0387949 0387971 0388147 0388177 0388382 0388543 0388640 0388751 0388837 0388902 0388953 0388957 0389035 0389057 0389156 0389188 0389194 0389408 0389457 0389592 0389666 0389717 0389861 0390089 0390170 0390420 0390566 0390656 0390663 0390787 0390813 0390901 0390932 0391073 0391131 0391134 0391137 0391141 0391156 0391213 0391378 0391411 0391590 0391636 0391745 0391767 0391769 0391778 0391780 0391795 0391928 0391980 0392021 0392103 0392109 0392110 0392148 0392253 0392810 0392877 0392986 0393132 0393210 0393225 0393239 0393250 0393348 0393581 0393595 0393765 0394033 0394105 0394167 0394182 0394261 0394353 0394362 0394365 0394370 0394659 0394686 0395067 0395177 0395301 0395353 0395376 0395378 0395418 0395504 0395690 0395707 0395737 0396175 0396190 0396496 0396569 0396649 0396685 0396705 0396766 0396980 0397077 0397117 0397197 0397202 0397233 0397518 0397591 0397677 0397869 0397922 0397950 0398003 0398091 0398151 0398309 0398322 0398329 0398388 0398686 0398777 0398967 0399020 0399225 0399372 0399641 0399838 0399976 0400067 0400201 0400373 0400396 0400432 0400446 0400554 0400610 0400777 0401110 0401124 0401232 0401325 0401372 0401543 0401778 0401894 0401931 0401932 0402048 0402050 0402053 0402126 0402238 0402309 0402342 0402496 0402529 0402532 0402581 0402784 0402958 0402965 0403006 0403040 0403181 0403215 0403223 0403235 0403272 0403578 0403617 0403857 0404019 0404092 0404116 0404179 0404210 0404395 0404489 0404509 0404637 0405045 0405095 0405336 0405434 0405596 0405598 0405653 0405766 0405780 0405837 0405858 0405876 0405974 0405989 0406073 0406087 0406605 0406629 0406985 0406990 0407313 0407602 0407927 0408057 0408073 0408576 0408822 0408838 0408972 0408978 0409203 0409271 0409425 0409842 0410290 0410358 0410359 0387667 0399505 0408717 0388334 0388335 0397436 0371799 0387267 0391583 0392628 0399021 0402758 0405711 0375312 0378419 0378105 0378613 0388331 0389621 0391980 0392110 0392995 0394055 0394362 0395231 0397427 0403422 0353373 0356495 0364728 0387267 0396029 0399256 0410347 0381002 0387758 0390304 0405217 0405218 0405219 0405221 0405222 0407738 0363138 0374618 0402263 0406514 0351046 0353907 0355925 0355926 0357502 0357672 0357926 0358404 0358415 0358511 0359123 0359134 0359561 0359702 0362261 0362309 0363867 0364018 0364229 0364429 0364865 0364992 0365127 0365602 0365757 0366207 0366217 0367041 0367165 0367743 0368197 0368439 0368771 0369163 0369500 0370069 0370627 0371232 0371373 0371788 0372178 0372239 0372266 0372280 0372458 0373421 0373440 0374126 0374551 0375282 0375304 0375312 0375487 0375489 0376282 0376882 0377064 0377585 0377588 0377792 0377989 0378665 0378692 0378772 0379238 0380004 0380020 0380670 0381139 0381482 0382439 0382718 0382853 0384227 0384681 0384917 0385228 0385280 0385372 0385682 0386305 0386325 0386441 0387285 0387423 0387503 0387547 0387730 0387767 0387883 0387926 0388055 0388069 0388075 0388382 0388592 0388618 0388714 0389122 0389154 0389185 0389194 0389243 0389362 0389384 0389387 0389568 0389587 0389612 0389728 0390080 0390314 0390414 0390554 0390559 0390615 0390928 0391065 0391155 0391270 0391589 0391688 0391776 0391839 0391849 0392012 0392218 0392684 0392708 0392784 0392874 0392913 0392919 0393150 0393445 0393556 0393674 0393885 0393954 0394103 0394226 0394269 0394619 0395392 0395559 0395673 0395750 0395817 0395965 0396153 0396726 0396905 0397138 0397224 0397263 0397277 0397357 0397552 0397597 0397869 0397873 0397951 0398374 0398510 0398737 0398785 0398848 0398969 0399043 0399132 0399270 0399291 0399324 0399355 0399397 0399558 0399570 0399769 0399815 0399826 0399913 0400157 0400484 0400803 0400972 0401176 0401201 0401248 0401278 0401331 0401452 0401459 0401519 0401609 0401794 0402061 0402253 0402290 0402682 0402775 0402862 0402914 0402977 0403003 0403205 0403376 0403433 0403476 0403819 0403869 0404024 0404052 0404467 0404504 0404619 0404760 0404761 0405239 0405278 0405299 0405563 0405895 0405936 0406011 0406254 0406257 0406341 0406618 0406620 0406769 0406804 0406894 0406921 0406929 0406958 0407458 0407586 0407755 0408144 0408157 0408200 0408454 0408491 0408644 0408650 0408697 0408770 0408775 0408814 0409160 0409192 0409285 0409389 0409513 0409534 0409543 0409702 0409746 0409937 0410060 0356463 0364721 0398128 0358695 0390090 0395334 0398588 0400260 0402183 0389573 0387868 0364528 0391435 0401281 0379041 0394110 0401953 0397789 0387304 0380828 0399269 0392386 0391113 0399126 0404236 0400626 0391903 0391903 0382810 0403207 0403207 0406057 0406607 0409616 0397662 0393453 0406077 0409838 0409873 0410231 0374253 0387543 0388084 0393997 0401856 0408058 0402296 0377151 0379588 0388900 0399473 0399755 0366554 0377151 0403687 0394456 0400565 0350179 0368608 0368608 0360853 0354352 0370347 0375782 0375705 0391515 0360852 0358054 0364542 0376210 0390255 0391158 0394455 0394832 0350205 0399580 0388757 0382301 Class II Lack of Assurance of Sterility: Franck's Lab Inc. initiated a recall of all Sterile Human Drugs distributed between 11/21/2011 and 05/21/2012. FDA environmental sampling revealed the presence of microorganisms and fungal growth in the clean room where sterile products were prepared. Franck's Lab Inc., d.b.a. Franck's Compounding Lab
Drugs TRIMIX/LIDOCAINE 11.8MG/0.39MG/10.6MCG/1.7MG/ML INJECTABLE 30 ML; TRIMIX/LIDOCAINE 13.6MG/0.45MG/38.2MCG/7.3MG/ML INJECTABLE 10 ML; TRIMIX/LIDOCAINE 12MG/1MG/5MCG/1%/ML INJECTABLE 10 MLS; TRIMIX/LIDOCAINE 17.65MG/0.59MG/5.9MCG/2% INJECTABLE 10 ML (4 DIFFERENT PRODUCTS) Rx #'s: 0389839 0389283 0404785 0390956 Class II Lack of Assurance of Sterility: Franck's Lab Inc. initiated a recall of all Sterile Human Drugs distributed between 11/21/2011 and 05/21/2012. FDA environmental sampling revealed the presence of microorganisms and fungal growth in the clean room where sterile products were prepared. Franck's Lab Inc., d.b.a. Franck's Compounding Lab
Drugs TROPICAMIDE OPHTHALMIC P.F. 1% SOLUTION 30 ML (1 PRODUCT) Rx #: 0382303 Class II Lack of Assurance of Sterility: Franck's Lab Inc. initiated a recall of all Sterile Human Drugs distributed between 11/21/2011 and 05/21/2012. FDA environmental sampling revealed the presence of microorganisms and fungal growth in the clean room where sterile products were prepared. Franck's Lab Inc., d.b.a. Franck's Compounding Lab
Drugs TROPICAMIDE/PHENYLEPHRINE OPHTHALMIC 15:1 SOLUTION 128 ML 480 ML 496 ML 576 ML 90 ML (5 DIFFERENT PRODUCTS) Rx #'s: 0394909 0394909 0394909 0394909 0394909 Class II Lack of Assurance of Sterility: Franck's Lab Inc. initiated a recall of all Sterile Human Drugs distributed between 11/21/2011 and 05/21/2012. FDA environmental sampling revealed the presence of microorganisms and fungal growth in the clean room where sterile products were prepared. Franck's Lab Inc., d.b.a. Franck's Compounding Lab
Drugs TRYPAN BLUE SOLUTION, P.F. 0.04% OPHTHALMIC 10 ML; TRYPAN BLUE SOLUTION, P.F. 0.05% OPHTHALMIC 0.5 ML 1.5 ML 10 ML 12 ML 2 ML 2.5 ML 3 ML 4 ML 4.5 ML 5 ML 6 ML 7.5 ML 8 ML; TRYPAN BLUE SOLUTION, P.F. 0.06% OPHTHALMIC 10 ML 2.5 ML; TRYPAN BLUE SOLUTION, P.F. 0.1% OPHTHALMIC 1 ML 1.5 ML 10 ML 12 ML 2 ML 25 ML 4 ML 5 ML 50 ML; TRYPAN BLUE SOLUTION, P.F. STSL (0.5ML SYRINGE, NO NEEDLE) 0.06% OPHTHALMIC 10 ML; TRYPAN BLUE, 0.75ML SYRINGE, LUER-LOK, STSL 0.1% OPHTHALMIC 3 ML 4.5 ML 9 ML; TRYPAN BLUE, 1ML SYRINGE, LUER-LOK, STSL 0.1% OPHTHALMIC 12 ML (30 DIFFERENT PRODUCTS) Rx #'s: 0396447 0391904 0396678 0393251 0400335 0402500 0352474 0368241 0387963 0394942 0402089 0394942 0400335 0352474 0368241 0393251 0395043 0368241 0393251 0403936 0409994 0391904 0349660 0368241 0388163 0390614 0391904 0401994 0402332 0402500 0393985 0368241 0403168 0402227 0403032 0395193 0396679 0397454 0396679 0387480 0387514 0397147 0401881 0405105 0409255 0397147 0403630 0397147 0401846 0387647 0390992 0397147 0403742 0402848 0402848 0402848 0399288 Class II Lack of Assurance of Sterility: Franck's Lab Inc. initiated a recall of all Sterile Human Drugs distributed between 11/21/2011 and 05/21/2012. FDA environmental sampling revealed the presence of microorganisms and fungal growth in the clean room where sterile products were prepared. Franck's Lab Inc., d.b.a. Franck's Compounding Lab
Drugs ULTRA-TEST 200 (CYP 80%/PROP 20%) 200MG/ML INJECTABLE 1 ML 10 ML 10 MLS 12 ML 15 ML 18 ML 2 ML 20 ML 20 MLS 24 ML 3 ML 30 ML 5 ML 6 ML 8 ML 9 ML; ULTRA-TEST 200 IN SESAME OIL (CYP 80%/PROP 20%) 200MG/ML INJECTABLE 10 ML 30 ML 8 ML; ULTRA-TEST 250 (CYP 80%/PROP 20%) 250MG/ML INJECTABLE 10 ML 20 ML (21 DIFFERENT PRODUCTS) Rx #'s:C0389434 C0389437 C0389439 C0389440 C0389441 C0389442 C0389444 C0389445 C0389446 C0389447 C0389448 C0389449 C0389450 C0389451 C0389452 C0389453 C0389454 C0389455 C0391550 C0397034 C0402354 C0372981 C0377330 C0380467 C0380957 C0381304 C0382133 C0383978 C0384095 C0385948 C0385973 C0385977 C0385980 C0386103 C0387091 C0387437 C0387546 C0387549 C0387587 C0387588 C0387589 C0387733 C0387734 C0387736 C0387738 C0387753 C0388095 C0388096 C0388097 C0388098 C0388099 C0388100 C0388101 C0388107 C0388208 C0388209 C0388211 C0388212 C0388216 C0388217 C0388247 C0388248 C0388341 C0388349 C0388379 C0388875 C0388877 C0388878 C0388879 C0388881 C0388948 C0388950 C0388951 C0388952 C0388954 C0388956 C0388959 C0388961 C0388964 C0388965 C0388967 C0388968 C0388969 C0388970 C0388971 C0388972 C0388973 C0388975 C0388976 C0388977 C0388978 C0388979 C0388982 C0388984 C0388986 C0388987 C0388990 C0388994 C0388997 C0388998 C0389000 C0389002 C0389003 C0389005 C0389007 C0389008 C0389010 C0389011 C0389013 C0389014 C0389016 C0389018 C0389019 C0389020 C0389021 C0389024 C0389028 C0389413 C0389415 C0389685 C0389738 C0389822 C0389917 C0389918 C0389919 C0389921 C0389923 C0389925 C0389927 C0389929 C0389931 C0389932 C0389933 C0389935 C0389937 C0389938 C0389939 C0389940 C0389942 C0389943 C0389945 C0389958 C0389959 C0389960 C0389961 C0389962 C0389964 C0389966 C0389969 C0389970 C0389971 C0389980 C0389990 C0390034 C0390035 C0390257 C0390258 C0390259 C0390263 C0390266 C0390268 C0390270 C0390274 C0390281 C0390283 C0390287 C0390290 C0390378 C0390381 C0390386 C0390432 C0390435 C0390436 C0390437 C0390438 C0390439 C0390440 C0390441 C0390442 C0390443 C0390444 C0390446 C0390447 C0390448 C0390449 C0390450 C0390451 C0390452 C0390453 C0390454 C0390666 C0390667 C0390669 C0390670 C0390683 C0390685 C0390687 C0390688 C0390690 C0390691 C0390694 C0390696 C0390698 C0390699 C0390701 C0390707 C0390711 C0390712 C0390750 C0390752 C0390753 C0390756 C0390758 C0390759 C0390760 C0390762 C0390767 C0390769 C0390778 C0390780 C0390785 C0390795 C0390796 C0390797 C0391096 C0391193 C0391194 C0391364 C0391365 C0391366 C0391367 C0391368 C0391369 C0391379 C0391380 C0391398 C0391504 C0391613 C0391616 C0391619 C0391622 C0391870 C0391874 C0391966 C0392116 C0392142 C0392350 C0392458 C0392461 C0392463 C0392464 C0392465 C0392466 C0392468 C0392471 C0392472 C0392474 C0392475 C0392476 C0392477 C0392478 C0392479 C0392480 C0392481 C0392482 C0392483 C0392484 C0392485 C0392486 C0392487 C0392488 C0392489 C0392490 C0392491 C0392492 C0392493 C0392494 C0392495 C0392496 C0392497 C0392498 C0392499 C0392500 C0392501 C0392504 C0392722 C0392728 C0392738 C0392739 C0392742 C0392746 C0392749 C0392754 C0392757 C0392760 C0392761 C0392763 C0393120 C0393135 C0393137 C0393138 C0393139 C0393140 C0393142 C0393143 C0393144 C0393145 C0393146 C0393147 C0393148 C0393149 C0393151 C0393152 C0393153 C0393154 C0393155 C0393157 C0393159 C0393182 C0393259 C0393260 C0393265 C0393466 C0393551 C0393627 C0393631 C0393632 C0393638 C0393719 C0393720 C0393721 C0393763 C0393780 C0393834 C0393840 C0393842 C0393845 C0393847 C0393849 C0393850 C0393851 C0393853 C0393854 C0393855 C0393856 C0393858 C0393860 C0393861 C0393862 C0393863 C0393865 C0393867 C0393868 C0393870 C0393872 C0393873 C0393875 C0393950 C0393988 C0394308 C0394313 C0394314 C0394884 C0394885 C0394887 C0394888 C0394890 C0394891 C0394912 C0394919 C0394939 C0394940 C0394952 C0394953 C0394956 C0394958 C0394962 C0395009 C0395012 C0395014 C0395015 C0395018 C0395020 C0395021 C0395022 C0395023 C0395024 C0395026 C0395027 C0395028 C0395029 C0395030 C0395073 C0395076 C0395588 C0396178 C0396305 C0396307 C0396308 C0396309 C0396310 C0396316 C0396320 C0396341 C0396407 C0396457 C0396480 C0396551 C0396552 C0396936 C0397031 C0397044 C0397049 C0397050 C0397055 C0397057 C0397058 C0397062 C0397318 C0397320 C0397675 C0398068 C0398072 C0398087 C0398088 C0398090 C0398094 C0398095 C0398096 C0398097 C0398098 C0398099 C0398100 C0398102 C0398104 C0398106 C0398109 C0398112 C0398113 C0398341 C0398342 C0398393 C0398399 C0398401 C0398407 C0398408 C0398410 C0398412 C0398413 C0398414 C0398416 C0398417 C0398418 C0398419 C0398420 C0398421 C0398422 C0398423 C0398424 C0398425 C0398426 C0398427 C0398428 C0398429 C0398431 C0398432 C0398433 C0398434 C0398435 C0398436 C0398437 C0398438 C0398439 C0398440 C0398441 C0398442 C0398443 C0398444 C0398445 C0398446 C0398447 C0398448 C0398449 C0398450 C0398451 C0398452 C0398453 C0398454 C0398455 C0398456 C0398457 C0398458 C0398459 C0398460 C0398461 C0398462 C0398463 C0398464 C0398465 C0398466 C0398467 C0398468 C0398469 C0398470 C0398471 C0398472 C0398473 C0398474 C0398475 C0398476 C0398477 C0398478 C0398479 C0398480 C0398481 C0398482 C0398483 C0398484 C0398485 C0398486 C0398487 C0398488 C0398489 C0398490 C0398491 C0398492 C0398493 C0398494 C0398495 C0398496 C0398497 C0398498 C0398499 C0398558 C0398560 C0398561 C0398749 C0398750 C0398752 C0398754 C0398756 C0398797 C0398806 C0398944 C0398946 C0398947 C0399113 C0399115 C0399116 C0399117 C0399118 C0399119 C0399120 C0399121 C0399122 C0399204 C0399210 C0399212 C0399306 C0399308 C0399309 C0399310 C0399311 C0399313 C0399314 C0399315 C0399316 C0399317 C0399318 C0399321 C0399389 C0399391 C0399589 C0399592 C0399593 C0399594 C0399595 C0399596 C0399840 C0400185 C0400186 C0400188 C0400313 C0400316 C0400318 C0400321 C0400323 C0400324 C0400330 C0400357 C0400358 C0400361 C0400363 C0400365 C0400366 C0400368 C0400369 C0400370 C0400371 C0400376 C0400379 C0400381 C0400386 C0400387 C0400389 C0400390 C0400391 C0400392 C0400538 C0400541 C0400812 C0400820 C0400852 C0400854 C0400858 C0400860 C0401161 C0401257 C0401988 C0402422 C0402424 C0402428 C0402430 C0402434 C0402438 C0402441 C0402442 C0402444 C0402445 C0402447 C0402450 C0402452 C0402454 C0402455 C0402456 C0402458 C0402459 C0402461 C0402462 C0402463 C0402885 C0402886 C0402887 C0402888 C0402937 C0403305 C0403378 C0403397 C0403495 C0403496 C0403527 C0403624 C0403794 C0403864 C0403865 C0403866 C0403868 C0403870 C0403872 C0404368 C0404370 C0404642 C0404935 C0405125 C0405126 C0405127 C0405128 C0405129 C0405130 C0405131 C0405132 C0405133 C0405134 C0405135 C0405136 C0405137 C0405138 C0405139 C0405345 C0405511 C0405537 C0405539 C0405549 C0405551 C0405559 C0405815 C0405833 C0405839 C0405854 C0406127 C0406137 C0406139 C0406140 C0406236 C0406240 C0406378 C0406381 C0406383 C0406788 C0406876 C0407040 C0407189 C0407191 C0407193 C0407195 C0407197 C0407201 C0407203 C0407204 C0407206 C0407210 C0407212 C0407215 C0407216 C0407217 C0407259 C0407273 C0407275 C0407276 C0407278 C0407280 C0407282 C0407305 C0407316 C0407317 C0407319 C0407328 C0407331 C0407333 C0407335 C0407570 C0407678 C0407679 C0407681 C0407682 C0407683 C0407687 C0407689 C0407690 C0407692 C0407694 C0407695 C0407696 C0407697 C0407837 C0407840 C0407882 C0407883 C0407898 C0407899 C0407901 C0407902 C0407904 C0407906 C0407976 C0407977 C0407980 C0407982 C0407984 C0407985 C0407986 C0408008 C0408017 C0408019 C0408020 C0408217 C0408220 C0408249 C0408402 C0408406 C0408408 C0408411 C0408412 C0408413 C0408414 C0408416 C0408418 C0408420 C0408422 C0408424 C0408425 C0408426 C0408429 C0408431 C0408432 C0408433 C0408434 C0408435 C0408437 C0408439 C0408440 C0408441 C0408443 C0408444 C0408445 C0408446 C0408448 C0408452 C0408455 C0408456 C0408457 C0408460 C0408461 C0408463 C0408464 C0408465 C0408466 C0408469 C0408472 C0408479 C0408481 C0408483 C0408484 C0408485 C0408488 C0408492 C0408493 C0408495 C0408507 C0408508 C0408509 C0408513 C0408518 C0408528 C0408531 C0408532 C0408533 C0408534 C0408541 C0408542 C0408543 C0408553 C0408558 C0408569 C0408571 C0408574 C0408577 C0408579 C0408580 C0408581 C0408582 C0408584 C0408586 C0408588 C0408590 C0408591 C0408592 C0408593 C0408594 C0408596 C0408597 C0408606 C0408607 C0408608 C0408627 C0408628 C0408629 C0408635 C0408646 C0408647 C0408648 C0408655 C0408656 C0408657 C0408905 C0409134 C0409136 C0409140 C0409141 C0409142 C0409143 C0409210 C0409334 C0409637 C0409639 C0409640 C0409642 C0409643 C0409645 C0409648 C0409649 C0409651 C0409653 C0409657 C0409668 C0409670 C0409675 C0409682 C0409686 C0409687 C0409688 C0409690 C0409693 C0409696 C0409748 C0409750 C0409754 C0391538 C0388196 C0388439 C0388454 C0390740 C0390741 C0390742 C0390743 C0390744 C0390745 C0392558 C0392727 C0394387 C0394806 C0394808 C0394810 C0394812 C0394813 C0394815 C0394816 C0394817 C0394818 C0394819 C0394822 C0394823 C0397368 C0399961 C0399967 C0400574 C0400580 C0400582 C0400586 C0400589 C0400592 C0400593 C0400596 C0400600 C0400602 C0400605 C0400607 C0403652 C0403653 C0403655 C0403656 C0403658 C0403659 C0403661 C0403667 C0403670 C0403671 C0403672 C0403675 C0403679 C0403681 C0403684 C0403685 C0403688 C0403690 C0403699 C0403703 C0403705 C0403706 C0403707 C0403708 C0403709 C0403716 C0403717 C0403962 C0403965 C0403966 C0403967 C0403969 C0403970 C0403971 C0403974 C0403975 C0403978 C0403980 C0403981 C0404151 C0404361 C0404393 C0405479 C0405808 C0406203 C0406420 C0406652 C0407055 C0407056 C0407060 C0407063 C0407066 C0407068 C0407071 C0407075 C0407076 C0407077 C0407089 C0407090 C0407091 C0407093 C0407094 C0407097 C0407098 C0407099 C0407104 C0407109 C0407114 C0407115 C0407125 C0407130 C0407131 C0407137 C0407141 C0407142 C0407149 C0407150 C0407151 C0407152 C0407593 C0407823 C0408239 C0408247 C0408258 C0408261 C0408263 C0408273 C0408282 C0408286 C0408288 C0408291 C0408293 C0408294 C0408524 C0409224 C0389431 C0400348 C0405848 C0400181 C0385989 C0387410 C0395585 C0409001 C0410097 C0387938 C0387939 C0390264 C0390612 C0390799 C0393032 C0394401 C0394402 C0394406 C0394411 C0394412 C0394421 C0394911 C0397033 C0397035 C0397052 C0397053 C0397056 C0397059 C0402127 C0403071 C0403072 C0403074 C0403092 C0403230 C0404392 C0404882 C0404884 C0404888 C0405616 C0405829 C0405845 C0405852 C0409919 C0398505 C0397373 C0405192 C0390937 C0391534 C0389190 C0379575 C0379730 C0393090 C0393436 C0393458 C0394915 C0401063 C0401064 C0405248 C0407719 C0409133 C0410114 C0387542 C0387788 C0389364 C0389576 C0390789 C0391052 C0391705 C0392428 C0393672 C0393705 C0394343 C0395670 C0397735 C0399114 C0399123 C0399124 C0399974 C0400164 C0403477 C0404042 C0405970 C0405990 C0406189 C0407782 C0410324 C0401084 C0407386 C0403187 C0391098 C0391110 C0391112 C0391115 C0391120 C0391123 C0396129 C0396130 C0396132 C0396133 C0396134 C0396135 C0401156 C0401162 C0401163 C0401164 C0401166 C0401167 C0408842 C0408844 C0408847 C0408849 C0408853 C0408856 C0374117 C0398680 C0383122 C0383125 C0383148 C0383149 C0391033 C0405334 C0405335 C0405338 C0391033 Class II Lack of Assurance of Sterility: Franck's Lab Inc. initiated a recall of all Sterile Human Drugs distributed between 11/21/2011 and 05/21/2012. FDA environmental sampling revealed the presence of microorganisms and fungal growth in the clean room where sterile products were prepared. Franck's Lab Inc., d.b.a. Franck's Compounding Lab
Drugs VANADYL SULFATE SOLUTION 200MCG/ML INJECTABLE 60 ML (1 PRODUCT) Rx #'s: 0402124 Class II Lack of Assurance of Sterility: Franck's Lab Inc. initiated a recall of all Sterile Human Drugs distributed between 11/21/2011 and 05/21/2012. FDA environmental sampling revealed the presence of microorganisms and fungal growth in the clean room where sterile products were prepared. Franck's Lab Inc., d.b.a. Franck's Compounding Lab
Drugs VANCOMYCIN (INTRAOCULAR) OPHTHALMIC, P.F. (BSS) 0.4% (4MG/ML) (0.4MG/0.1ML) INJE 400 ML; VANCOMYCIN (INTRAOCULAR) OPHTHALMIC, P.F. 1MG/0.1ML (10MG/ML) INJECTABLE 0.1 ML 0.2 ML 1 ML 100 ML 150 ML 2 ML 2 MLS 5 ML 50 ML 6 ML 95 ML; VANCOMYCIN HCL, FTV** 1GM INJECTABLE 3 VIAL 4 VIAL; VANCOMYCIN, FORTIFIED 1% (10MG/ML) OPHTHALMIC 10 ML; VANCOMYCIN, FORTIFIED 1.5% (15MG/ML) OPHTHALMIC 15 ML; VANCOMYCIN, FORTIFIED 2% (20MG/ML) OPHTHALMIC 10 ML 15 ML; VANCOMYCIN, FORTIFIED 2.5% (25MG/ML) OPHTHALMIC 10 ML 15 ML; VANCOMYCIN, FORTIFIED 5% (50MG/ML) OPHTHALMIC 10 ML 15 ML 5 ML; VANCOMYCIN, LYOPHILIZED, OPHTHALMIC KIT 1% KIT 1 KIT 1 VIAL 14 KIT 2 KIT 2 KITS 20 KIT 3 KIT 3 KITS 4 KIT 4 KITS 4 VIALS 5 KIT 6 KIT 6 VIAL 9 KIT; VANCOMYCIN, SDPF - (0.2ML SYRINGE, 30G, 1/2") 1% INJECTABLE 0.4 ML 0.6 ML 0.8 ML 1 ML 1.2 ML 1.6 ML (44 DIFFERENT PRODUCTS) Rx #'s: 0389516 0354047 0389060 0389207 0405939 0402042 0400827 0398001 0398001 0400827 0403914 0369558 0398001 0398001 0382651 0398001 0401260 0401260 0388232 0391059 0392294 0405026 0383386 0396250 0398226 0400971 0409026 0388709 0388791 0393212 0393212 0388791 0392126 0354819 0355230 0363386 0363473 0364197 0368230 0368499 0368573 0368881 0375045 0379341 0379553 0383464 0387849 0389351 0389391 0390955 0392188 0394445 0394681 0394937 0395427 0395954 0396732 0397082 0404021 0404798 0405706 0406017 0408990 0409845 0365234 0393460 0359175 0348859 0351904 0356879 0363386 0364197 0364237 0365742 0366033 0366278 0374625 0375045 0376068 0376172 0380555 0383380 0384293 0387373 0387484 0388897 0392019 0392074 0392237 0394445 0395775 0395954 0397082 0399965 0399990 0403522 0404021 0405332 0407337 0384730 0387512 0389305 0396300 0353129 0355934 0362691 0363386 0363664 0364588 0368573 0368881 0371798 0375690 0376829 0380347 0383380 0387484 0388897 0392019 0392331 0392542 0392778 0394517 0395954 0395388 0355439 0358613 0362691 0366278 0375410 0375512 0375513 0375516 0375517 0375520 0375690 0384293 0387482 0392331 0408623 0376092 0399725 0354424 0392778 0405107 0408480 0408826 0373371 0375355 0375502 0375505 0375508 0375509 0375512 0375513 0375516 0375517 0375520 0392019 0392331 0395775 0398876 0368828 0392019 0358047 0387426 0391713 0393523 0404318 0391713 0391703 0402014 0391703 Class II Lack of Assurance of Sterility: Franck's Lab Inc. initiated a recall of all Sterile Human Drugs distributed between 11/21/2011 and 05/21/2012. FDA environmental sampling revealed the presence of microorganisms and fungal growth in the clean room where sterile products were prepared. Franck's Lab Inc., d.b.a. Franck's Compounding Lab
Drugs VANCOMYCIN/DEXAMETHASONE, LYOPHILIZED 1%/0.1% KIT 2 KIT 20 KIT 24 KIT (3 DIFFERENT PRODUCTS) Rx #'s: 0397687 0366647 0366647 Class II Lack of Assurance of Sterility: Franck's Lab Inc. initiated a recall of all Sterile Human Drugs distributed between 11/21/2011 and 05/21/2012. FDA environmental sampling revealed the presence of microorganisms and fungal growth in the clean room where sterile products were prepared. Franck's Lab Inc., d.b.a. Franck's Compounding Lab
Drugs VERAPAMIL HCL 10MG/ML INJECTABLE 80 ML; VERAPAMIL HCL 20MG/ML INJECTABLE 50 ML; VERAPAMIL HCL, SDV*** (5X2ML VIAL) 2.5MG/ML INJECTABLE 20 MLS 40 ML 50 ML 50 MLS (6 DIFFERENT PRODUCTS) Rx #'s: 0405155 0401813 0405492 0397906 0401484 0401488 0401490 0395651 Class II Lack of Assurance of Sterility: Franck's Lab Inc. initiated a recall of all Sterile Human Drugs distributed between 11/21/2011 and 05/21/2012. FDA environmental sampling revealed the presence of microorganisms and fungal growth in the clean room where sterile products were prepared. Franck's Lab Inc., d.b.a. Franck's Compounding Lab
Drugs VITAMIN K (PHYTONADIONE) 10MG/ML INJECTABLE 1 ML 2 ML 4 ML; VITAMIN K (PHYTONADIONE) 5MG/ML INJECTABLE 2 ML; VITAMIN A AQUEOUS EMULSION 50,000 U/ML INJECTABLE 20 ML 40 ML; VITAMIN B COMPLEX (B1,B2,B3,B5,B6) 100/5/100/100/100MG/ML INJECTABLE 120 ML 150 ML 180 ML 90 ML VITAMIN B COMPLEX (B1,B2,B3,B5,B6,B12) INJECTABLE 10 ML 20 ML 40 ML VITAMIN B COMPLEX (B1,B2,B3,B5,B6/ASCORBIC ACID/B12) 12.5/2/12.5/5/5/1MG/1MG/ML 60 ML VITAMIN B COMPLEX -PF (B1,B2,B3,B5,B6) 12.5/12.5/12.5/12.5/12.5MG/ML INJECTABLE 40 ML VITAMIN B COMPLEX PF (B1,B2,B3,B5,B6,B12) INJECTABLE 10 ML VITAMIN B-6/VITAMIN B-12 100MG/1000MCG/ML INJECTABLE 5 ML VITAMIN B-COMPLEX 100*** (30ML) INJECTABLE 30 ML VITAMIN COMPLEX (ASCOR,B1,B2,B3,B5,B6,B12,METH,INOS,CHL,LID) DR. HOLLOWAY INJECT 180 ML 240 ML 30 ML 60 ML VITAMIN D3 IN SESAME OIL 10,000 IU/ML INJECTABLE 60 ML (23 DIFFERENT PRODUCTS) Rx #'s: 0396112 0396112 0390633 0399923 0392295 0397930 0405691 0357875 0371933 0370806 0371933 0357875 0371933 0373258 0373258 0373258 0391775 0397909 0391540 0371152 0401946 0409588 0391886 0391886 0391886 0391886 0391867 0400517 Class II Lack of Assurance of Sterility: Franck's Lab Inc. initiated a recall of all Sterile Human Drugs distributed between 11/21/2011 and 05/21/2012. FDA environmental sampling revealed the presence of microorganisms and fungal growth in the clean room where sterile products were prepared. Franck's Lab Inc., d.b.a. Franck's Compounding Lab
Drugs VORICONAZOLE OPHTHALMIC 1% (10MG/ML) SOLUTION 15 ML; VORICONAZOLE OPHTHALMIC, (0.5ML, LL SYRINGE), P.F. 0.1% (100MCG/0.1ML) INJECTABL 0.5 ML 1 ML 1.5 ML 2 ML 2.5 ML 5 ML; VORICONAZOLE OPHTHALMIC, P.F. (SINGLE DOSE ONLY) 0.1% (100MCG/0.1ML) INJECTABLE 0.1 ML 1 ML 5 ML (10 DIFFERENT PRODUCTS) Rx #'s: 0405994 0401042 0405007 0405945 0404546 0404819 0400172 0404384 0400172 0410164 0410169 0410172 0404101 0404101 0404546 0405739 0393586 0393587 0403026 0401576 Class II Lack of Assurance of Sterility: Franck's Lab Inc. initiated a recall of all Sterile Human Drugs distributed between 11/21/2011 and 05/21/2012. FDA environmental sampling revealed the presence of microorganisms and fungal growth in the clean room where sterile products were prepared. Franck's Lab Inc., d.b.a. Franck's Compounding Lab
Drugs ZINC CHLORIDE 10MG/ML INJECTABLE 30 ML 60 ML (2 DIFFERENT PRODUCTS) Rx #'s: 0398931, 0356347, 0398931 Class II Lack of Assurance of Sterility: Franck's Lab Inc. initiated a recall of all Sterile Human Drugs distributed between 11/21/2011 and 05/21/2012. FDA environmental sampling revealed the presence of microorganisms and fungal growth in the clean room where sterile products were prepared. Franck's Lab Inc., d.b.a. Franck's Compounding Lab
Drugs Carboplatin Injection, 10 mg/mL, a) 5 mL multi-dose vials (NDC 61703-339-18) (NDC 61703-360-18, NOVAPLUS), b) 45 mL multi-dose vials (NDC 61703-339-50) (NDC 61703-360-50 NOVAPLUS), Rx only, Hospira, Inc., Lake Forest, IL 60045, Product of Australia 5 mL vial - NDC 61703-339-18 (Hospira label), lot number Y031654AB, expiration APR2013; NDC 61703-360-18 (Novoplus label), lot number Y031654AA, expiration APR2013; 45 mL vial - NDC 61703-339-50 (Hospira label), lot numbers Y041711AA, expiration DEC 2012 and Y061711AB, expiration FEB 2013; NDC 61703-360-50 (Novoplus label), lot number Y061711AA, expiration FEB 2013 Class III Failed PH specification: The lots of Carboplatin Injection were manufactured from Carboplatin API lots which trended out of specification low pH. Hospira Inc.
Devices Maquet Getinge Group Pediatric Arterial Cannula Maquet Cardiopulmonary AG Kehler Strabe 31 76437 Rastatt Germany Phone +49 7222 932-0 Fax: +49 7222 932-1888 info.cp@maquet.com www.maquet.com Used to introduce blood and sterile solution to the circulation system during extracorporeal circulation procedures 510k023251 US Catalog Number 161412 Batch Number 92048923 Foreign Catalog number 161412 Batch number 92048923 Catalog number 161412 Batch number 92051578 Class II Certain pediatric arterial cannulas may have limited flexibility due to an increased length of the "hardened" cannula tip. Maquet Inc.
Devices The NCB Polyaxial Locking Plate System NCB screws 26mm: 02.03155.026, non-sterile Product is implantable screws indicated for temporary internal fixation and stabilization of fractures and osteotomies of long bones. These screws are intended for bicortical anchorage. Part number 02.03155.026, lot 2649941 Class II Zimmer investigation following a complaint found one lot of NCB Polyaxial Locking Plate System NCB screws, 26mm, distributed in the United States contained incorrect 32 mm screws. Zimmer, Inc.
Devices Trabecular Metal Reverse Shoulder Liner 40mm, part 00-4309-028-00 - Per surgical technique 97-4309-003-00 Revision 4: "Complete Poly Liner insertion by snapping the appropriate 60· (Standard) or 65· (Retentive) Poly Liner Impactor to the Poly Liner Impactor Handle. Then, place the Poly Liner Impactor on the Poly Liner articular surface and forcefully strike the Poly Liner Handle with a mallet." part 00-4309-028-00, lot 60443178, 60545332, 60549563, 60605851, 60612791, 60720047 60758647 60773944 60836577 60896973, 60973522, 61019783, 61024158 Class II Lot specific Trabecular Metal (TM) Reverse Shoulder Liner Impactors are being recalled due to reports of alignment peg fractures. All lots of TM Reverse Shoulder Liner Impactors manufactured from 455 stainless steel are being retrieved, as all reported fractured instruments were manufactured with this material. The TM Reverse Shoulder Liner Impactor units that were manufactured with 13-8 stainless steel are not affected by this action. Zimmer, Inc.
Devices 00-4309-028-01 - Trabecular Metal Reverse Shoulder Liner 40mm 65° Neck Angle Per surgical technique 97-4309-003-00 Revision 4: "Complete Poly Liner insertion by snapping the appropriate 60· (Standard) or 65· (Retentive) Poly Liner Impactor to the Poly Liner Impactor Handle. Then, place the Poly Liner Impactor on the Poly Liner articular surface and forcefully strike the Poly Liner Handle with a mallet." Part 00-4309-028-01: Lot 60529860, 60574377, 60589079, 60605856, 60616574, 60684774, 60842967, 60739623, 60896979, 60936815, 61019785, 61051017 Class II Lot specific Trabecular Metal (TM) Reverse Shoulder Liner Impactors are being recalled due to reports of alignment peg fractures. All lots of TM Reverse Shoulder Liner Impactors manufactured from 455 stainless steel are being retrieved, as all reported fractured instruments were manufactured with this material. The TM Reverse Shoulder Liner Impactor units that were manufactured with 13-8 stainless steel are not affected by this action. Zimmer, Inc.
Devices 00-4309-029-00- Trabecular Metal Reverse Shoulder Liner 36mm, Nonsterile Per surgical technique 97-4309-003-00 Revision 4: "Complete Poly Liner insertion by snapping the appropriate 60· (Standard) or 65· (Retentive) Poly Liner Impactor to the Poly Liner Impactor Handle. Then, place the Poly Liner Impactor on the Poly Liner articular surface and forcefully strike the Poly Liner Handle with a mallet." Part 00-4309-029-00: Lot 60444332, 60537066, 60549565, 60605852, 60612792, 60633381, 60708954, 60743404, 60773946, 60870480, 60915146, 60979391, and 61004027. Class II Lot specific Trabecular Metal (TM) Reverse Shoulder Liner Impactors are being recalled due to reports of alignment peg fractures. All lots of TM Reverse Shoulder Liner Impactors manufactured from 455 stainless steel are being retrieved, as all reported fractured instruments were manufactured with this material. The TM Reverse Shoulder Liner Impactor units that were manufactured with 13-8 stainless steel are not affected by this action. Zimmer, Inc.
Devices 00-4309-029-01 - Trabecular Metal Reverse Shoulder Liner 36 mm 65° Neck Angle Per surgical technique 97-4309-003-00 Revision 4: "Complete Poly Liner insertion by snapping the appropriate 60· (Standard) or 65· (Retentive) Poly Liner Impactor to the Poly Liner Impactor Handle. Then, place the Poly Liner Impactor on the Poly Liner articular surface and forcefully strike the Poly Liner Handle with a mallet." Part 00-4309-029-01: Lot 60535162, 60545338, 60576488, 60605855, 60637022, 60689253, 60772974, 60875277, 60918060, 60989817, 61011689, 61024161, and 61051024. Class II Lot specific Trabecular Metal (TM) Reverse Shoulder Liner Impactors are being recalled due to reports of alignment peg fractures. All lots of TM Reverse Shoulder Liner Impactors manufactured from 455 stainless steel are being retrieved, as all reported fractured instruments were manufactured with this material. The TM Reverse Shoulder Liner Impactor units that were manufactured with 13-8 stainless steel are not affected by this action. Zimmer, Inc.
Food Hannaford Meatball Panini - cold, UPC # 941260723096 Hannaford Meatball Panini - hot, UPC # 94126072102 Packaged in 10 oz plastic clamshell All date codes (sold until July 9, 2012) Class I Panini's were made in-store utilizing meatballs as an ingredient recalled for potential Listeria monocytogenes by the Manufacturer Buona Vita Inc. 1 S. Industrial BLVD Bridgeton, NJ 08302 Hannaford Bros.
Devices Shiley Reusable Cannula Low Pressure Cuffed Tracheostomy Tubes, model numbers (Worldwide) 8LPC, 8FEN; (Outside U.S.) 8FENJ, 8FENJ-S, 8LPC-S, 8FEN-S. Product Usage: The product is intended for use to bypass upper airway obstructions, provide long term ventilation, support and/or manage tracheal/bronchial secretions. The product is sold as sterile. The packaging may indicate either Covidien or Tyco as the manufacturer as the firm has transitioned from Tyco to Covidien over the past 4 years. United States distributed product includes: 8FEN lots 0910000342 to 1101001558 and 110300622X to 120600700X; 8LPC lots 0910000348 to 1101001823 and 110200327X to 120600351X. Product Distributed outside of the United States: 8FENJ lots 1003002176, 1004000412, and 120100433X. 8FEN-S lot 0910001010; 8FENJ-S lots 0910002075 to 1103002299 and 110601803X to 120402125X; and 8LPC-S lots 0910001002 to 1103002052 and 111000400X to 120600014X. Class I Covidien is recalling certain cuffed Shiley tracheostomy tubes due to consumer complaints related to the connections and functions of the inner and outer cannula which were observed during mechanical ventilation of patients. Nellcor Puritan Bennett Inc. (dba Covidien LP)
Devices Philips Easy Diagnost Classic-Stationary x-ray system Catalog Numbers: 70642, 70643, 706030, 706031, 706032 Stationary x-ray system, Universal RF system for general use. Serial Numbers: SN07000141 SN07000109 SN5000162 SN5000421 SN07000667 200148 200115 200081 300114 Class II Inclination switch in the stand may have been mounted incorrectly, as a result, the switch could not stop the tilting movement of the table base due tol hardware or software errors. Philips Healthcare Inc.
Devices COBAS AmpliPrep Sample Tube Input Barcode Clips, catalog number 03137040001. Input S-tube barcode clips hold sample input tubes in the COBAS AmpliPrep Instrument (CAP) sample racks and have a barcode to identify the sample. Lot Numbers: 11049503, 11053503, 11054503, 11525503 and 11526503. Class II Certain lots of COBAS AmpliPrep (CAP) S-tube Input (Box of 12 bags 12x24 S-tube and 12x24 S-clip) can cause the sample input tubes to stick in the barcode clips. As a consequence, the CAP instrument will lift both the sample input tube together with the barcode clip from the sample rack, resulting in an aborted run. No erroneous results would be produced if the issue occurs, but samples in process would be aborted and would require re-running. Roche Molecular Systems, Inc.
Devices 13.5 mm x 50 mm BrainPath Sheath The NICO BrainPath is a family of products that consists of multiple sized reusable and re-sterilizable obturators with coordinating single patient use, disposable sheaths (three lengths available for each: 50mm, 60mm, and 75mm). The obturator and sheath are assembled in the OR immediately prior to use. These two components are held together by an interference fit. The device when used as intended is designed to provide access to neurological tissues. REF: NN-8011 - LOT: 80344-TD00214 (manufactured on 11-April-2012) Class II BrainPath sheaths were mislabeled. Sheaths which measure 50mm were labeled as 60mm. The length callout on the label does not match the actual length of the sheath within the packaging resulting in an improper fit as further explained below. This mislabeling was discovered on 29-June-2012 during a clinical case. Nico Corp.
Devices 13.5 mm x 60 mm BrainPath Sheath The NICO BrainPath is a family of products that consists of multiple sized reusable and re-sterilizable obturators with coordinating single patient use, disposable sheaths (three lengths available for each: 50mm, 60mm, and 75mm). The obturator and sheath are assembled in the OR immediately prior to use. These two components are held together by an interference fit. The device when used as intended is designed to provide access to neurological tissues. REF: NN-8012 - LOT: 80345-TD00214 (manufactured on 11-April-2012) Class II BrainPath sheaths were mislabeled. Sheaths which measure 50mm were labeled as 60mm. The length callout on the label does not match the actual length of the sheath within the packaging resulting in an improper fit as further explained below. This mislabeling was discovered on 29-June-2012 during a clinical case. Nico Corp.
Devices SenTec, V-Sign"2 Sensors The SenTec Digital Monitoring System (SMDS) is used for continuous and noninvasive real-time monitoring of ventilation (tcPCO2) and oxygenation (SpO2). 310701 311100 311239 310996 311920 311943 311958 312132 Class II SenTec is recalling a number of V-Sign"2 Sensors due to a problem regarding configuration parameter writing during manufacturing. Sentec AG
Devices Synthes(R) Hemostatic Bone Putty, Part numbers 08.901.001.97S, 08.901.001.98S, 08.901.001.99S, 08.901.001D, and VB1025.10S. Indicated for use as a water soluble implant material and for use in the control of bleeding from bone surfaces. All lot numbers associated with the identified part numbers. Class I There is the potential for Hemostatic Bone Putty to ignite if contacted with electrosurgical cautery systems under certain conditions during surgery. Synthes USA HQ, Inc.
Devices TAUT, Cholangiogram Catheter Intraducer, Peritoneal Catheter, Teleflex Medical, Research Triangle Park, NC. An introduction/drainage catheter accessory is intended to aid in the manipulation of or insertion of the device into the body. Catalog number: PI-128, Lot number: 01C200424, 01C1200425 and 01C1200426. Class III Product is missing the label on the internal packaging. Teleflex Medical
Drugs Derma-Smoothe/FS (Fluocinolone Acetonide) 0.01% Topical Oil (Scalp Oil), 4 fl oz (118.28mL) bottle, Rx only, FOR TOPICAL USE ONLY NOT, Manufactured and Distributed by: Hill Dermaceuticals, Inc. SANFORD, FLORIDA --- NDC 28105-149-04 Lot Numbers: -Scalp Oil: H100084 (exp 08/12), H100086 (08/12), J100093 (exp 08/12), J100094 (exp 09/12), J100097 (exp 09/12), K100101 (exp 09/12), K100103 (exp 10/12), K100104 (exp 10/12), K100108 (exp 10/12), K100112 (exp 10/12), L100860 (exp 11/12), L100890 (exp 11/12), L100910 (exp 11/12). Class III Subpotent; fluocinolone acetonide Hill Dermaceuticals, Inc.
Drugs Derma-Smoothe/FS (Fluocinolone Acetonide) 0.01%, Body Oil, 4 fl. oz. (118.28mL ), Rx only, FOR TOPICAL USE ONLY, Manufactured and Distributed by: Hill Dermaceuticals, Inc. SANFORD, FLORIDA --- NDC 28105-150-04 Lot Numbers: -Body Oil: J100095 (exp 09/12), J100099 (exp 09/12), K100106 (exp 10/12), K100111 (exp 10/12), L100872 (exp 11/12), L100880 (exp 11/12), D110560 (exp 04/13). Class III Subpotent; fluocinolone acetonide Hill Dermaceuticals, Inc.
Devices VITROS Chemistry Products DGXN Slides --- [REF] 834 3386. Product is packaged in a box with multiple slides. The lot and expiration codes are found on the side of the package. Product Usage: Intended use: For in vitro diagnostic use only. VITROS Chemistry Products DGXN Slides quantitatively measure digoxin (DGXN) concentration in serum and plasma using VITROS 250/350/950/5,1 FS and 4600 Chemistry Systems and the VITROS 5600 Integrated System. Lots from coating 0204, 0205, 0206. A Coating (CTG) is a unique identifier within the Lot Number of some of OCDs products Class II Ortho Clinical Diagnostics revised the VITROS Chemistry Products DGXN Slides Instructions for Use (IFU) and removed heparin plasma as a recommended specimen type for VITROS DGXN Slides Ortho-Clinical Diagnostics
Food Chiclets Chewing Gum Fruit Flavors; Made in Lebanon; Manufactured by Cadbury Adams Middle East S.A.L. All packages containing the Ingredient: E122-Carmoisine; NDC 5010455775472 Class II Baroody Imports Inc. is voluntarily recalling Chiclets Chewing Gum (Fruit Flavors) due to Misbranded/Unsafe Color Additives. Baroody Imports Inc.
Devices IMPAX Cardiovascular (CV) Reporting Reporting tool used for structured reporting and structured report outputs (including XML style sheet customization and PDF) Model # L9M2100 - All Software versions of IMPAX CV Reporting Class II Content entered into the "Conclusions" free text box on the Report Writer screen was not represented on the final printed report. AGFA Corp.
Food Southern Home Pasta Salad Ranch with Bacon, 7.5 oz., UPC 0788002891, 12 packages per case 051713CB85, exp. 5/17/13; 051813CA85 , exp. 5/18/13; 051813CB85, exp. 5/18/13 Class II Products may contain metal fragments Southern Home
Food Southern Home Pasta Salad Creamy Parmesan, 6.2 oz., UPC 0788002892, 12 packages per case 042013CA85, exp. date 4/20/13; 052113CA85, exp. dated 5/21/13 Class II Products may contain metal fragments Southern Home
Devices Philips Essenta DR, X-Ray System, Diagnostic, general-purpose Model: 712070. The Essenta DR is a multifunctional stationary X-ray Intended Use From Labeling): system, in which the swivel arm rotation, the vertical movement of the swivel arm and the SID adjustment are motorized. It is designed for radiographic examination of the recumbent, standing or seated patient and also for lateral exposures. It enables the operator to quickly and safely move the unit to all the pre-programmed basic positions at the press of a button, using the autopositioning feature. Fine positioning of the tube/collimator and detector on the patient is easy to carry out using the command arm. Serial Numbers: SN09000006/ SN09000007/ SN10000033/ SN10000014/ SN100000654/ SN08000092/ SN08000050 Class II Essenta DR C-Arm may fall Philips Healthcare Inc.
Veterinary Catswell Brand Vitakitty Chicken Breast with Flaxseed and Vitamins, 2 oz. Packaged in re-sealable 2 oz orange plastic bag with clear window. Lot codes affected are as follows: SEW12CH032701/03c and SEW12CH032702/03c with a best before date of 09/10/13 and 09/11/13, respectively (UPC code 8 84244 00057 2) Class II The product was recalled because it has the potential to contain propylene glycol. Dogswell Llc
Food 4/5 SYS SLICED YELLOW ONIONS, 720621 SUPC 1232222, Distributed by: SYSCO Codes: 3164, 3174, 3184, 3194 Class I Onions that firm further processed may be contaminated with Listeria monocytogenes. St Clair Foods, Inc.
Food 4/5 SYS DICED YELLOW ONIONS, 720611 SUPC 7750243, Distributed by: SYSCO Codes: 3164, 3174, 3184, 3194 Class I Onions that firm further processed may be contaminated with Listeria monocytogenes. St Clair Foods, Inc.
Food NO LABEL. Sub sandwiches are prepared fresh - made to order - wrapped in paper and then a generic label applied. The scale label would only state 1/2 sub or whole sub and the price from the Publix Deli. Publix does not have a mechanism to track sub sandwiches prepared with fresh onions. None Class I On July 29, 2012 Publix Super Markets, Inc. issued a voluntary recall for custom made sub sandwiches that contain onions because they may be adulterated with Listeria monocytogenes. Publix received notification from their supplier, who receives sliced onions from Gills Onions LLC. This recall involves any custom made sub sandwich with onions sold from the Publix Deli department between July 7, 2012 through July 26, 2012 in Alabama, Georgia, Tennessee, and South Carolina. Publix stores in Florida are not involved with this recall. Publix Super Markets, Inc.
Devices System 8000 Base Product Usage: The Sarns Modular Perfusion System 8000 is indicated for use for up to 6 hours on the extracorporeal circulation of blood for arterial perfusion, regional perfusion, and cardiopulmonary bypass procedures, when used by a qualified medical professional who is experienced in the operation of this or similar equipment. catalog number: 16401 and serial number: 2001, 2002, and 2003. Class III During a retrospective review of complaint events, TCVS identified on 06/15/12 that three (3) Sarns" System 8000 bases were manufactured and distributed from 11/13/06-11/29/06 with an incorrect incorrect amperage rating identified on the name plate label. The mislabeling was identified in January 2007 a set up process of the automark label printer. All units were corrected in the field in March 2007 by replacing the incorrect label at the customer location. The action was not reported to FDA at that time. Terumo Cardiovascular Systems Corporation
Devices DePuy Custom Implant Devices Packaging: Packaging was not standardized on customs, it was dependant on the geometry of the product Product Usage: Description: Devices meeting the regulatory definition of a custom medical device are those which are provided by prescription at a physician s request to meet a specific patient need and have been exempt from FDA premarket review under the Federal Food, Drug, and Cosmetic Act since 1976. Intended Use: See information contained in the Information for Use for Custom Implant Device (IFU-0902-00-500 rev C) Part Number: 101178997, 101201997, 101201998, 101201999, 101201999, 101214999, 101402998, 101402999, 101403999, 101436996, 101436997, 101466996, 101466997, 101466997, 101466997, 101466997, 101467996, 101467997, 101467997, 101467997, 101467997, 101467998, 101468997, 101468997, 101468997, 101468997, 101468999, 101469996, 101469997, 101469997, 101469997, 101469997, 101469997, 101470996, 101470997, 101470997, 101470997, 101470997, 101470999, 101471997, 101471997, 101471997, 101471997, 101471997, 101472990, 101472991, 101472992, 101472993, 101480961, 101480962, 101480963, 101480964, 101480977, 101480978, 101480983, 101480984, 101480985, 101480988, 101480989, 101480992, 101480993, 101480998, 101480999, 101580988, 101580989, 101580990, 101580991, 101580992, 101580993, 101580994, 101580995, 101811936, 101811936, 101811992, 101811994, 101811996, 101812935, 101812936, 101812993, 101812994, 101812995, 101812996, 101812998, 101813936, 101813936, 101813985, 101813988, 101813989, 101813990, 101813991, 101813992, 101813993, 101813994, 101813995, 101813998, 101814935, 101814935, 101814936, 101814936, 101814989, 101814990, 101814991, 101814992, 101814993, 101814994, 101814994, 101814995, 101814998, 101836862, 101836863, 101836864, 101836865, 101836866, 101836867, 101836868, 101836869, 101836870, 101836871, 101836871, 101836872, 101836873, 101836877, 101836878, 101836879, 101836880, 101836882, 101836883, 101836886, 101836887, 101836888, 101836889, 101836891, 101836892, 101836893, 101836895, 101836896, 101836897, 101836898, 101836899, 101836900, 101836900, 101836900, 101836903, 101836903, 101836903, 101836903, 101836905, 101836905, 101836908, 101836908, 101836908, 101836911, 101836911, 101836911, 101836976, 101836976, 101836977, 101836979, 101836980, 101836981, 101836984, 101836994, 101836996, 101836997, 101836998, 101836999, 101838999, 101839999, 101840972, 101840973, 101840974, 101840975, 101840976, 101840978, 101840979, 101840980, 101840981, 101840991, 101840992, 101840993, 101840994, 101840996, 101840998, 101840999, 101844988, 101844991, 101844992, 101844993, 101844994, 101844997, 101844998, 101844999, 101871936, 101871936, 101871979, 101871980, 101871983, 101871986, 101871987, 101871988, 101871989, 101871990, 101871991, 101871994, 101871995, 101871996, 101871997, 101875936, 101875936, 101875968, 101875969, 101875970, 101875971, 101875973, 101875974, 101875975, 101875976, 101875977, 101875978, 101875980, 101875981, 101875982, 101875984, 101875985, 101875986, 101875987, 101875988, 101875989, 101950999, 101950999, 101950999, 101952999, 101952999, 101959999, 102403999, 102405985, 102405986, 102405988, 102405990, 102405992, 102405994, 102405995, 102405996, 102405997, 102405999, 102407998, 102407999, 102408998, 102408999, 102451998, 102451999, 102452999, 102944993, 102944994, 102946991, 102946991, 102946992, 102950991, 102950992, 102950993, 102950994, 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LOT NUMBER: T1WAT1001, YE8FW1000, YE8FK1000, V43EN1001, V85EF1001, E15AH1, 129320, Y33AY1000, XV5DL1001, BR6HD1000, BR6HC1000, XH7GR1001, V2FC11001, V2FC11001, V3KD81001, V3KD81001, XH7GS1001, V2FCW1001, V2FCW1001, V3BKE1001, V3BKE1001, VN8FT1001, V2FCP1001, V2FCP1001, V2FCP1002, V2FCP1002, VN8FV1001, XH7GT1001, V2FBL1001, V2FBL1001, V3BKA1001, V3BKA1001, WB8KL1001, XK5FX1001, V2FBN1001, V2FBN1001, V3BKC1001, V3BKC1001, VN8FW1001, V2FBR1001, V2FBR1001, V2FBR1001, V2FBR1002, V2FBR1002, T3HJ11001, T2HBJ1001, T1KAA1001, T1KAB1001, 174934, 167652, 111473, FJ9KD1, BW5GE1000, A3NCR1000, ZS5FG1000, X2EE91000, X2EFA1000, XT5HD1001, VP9EW1001, U3NH51001, U3NH61001, C2TAD1, C2TAC1, DF3A41, B36H61000, BD9AD1000, A1HE31000, ZF3D91000, ZE6A11000, XH7H91001, UR6EP1001, V44AT1001, V44AT1001, BB1E91000, WX9FL1001, V5CDH1001, V5KJT1001, V18FK1001, W39AA1001, WX9F81001, WW5FN1001, V5CDJ1001, VT4HB1001, V18FM1001, V44BH1001, XH7G51001, W3KFF1001, W2DGN1001, W1VJ71001, WX9F91001, WW5FW1001, V44JS1001, V5CDK1001, V3TAN1001, VT4HC1001, V5KJR1001, V5KJR1001, V18FN1001, V44B51001, W36AD1001, W2CJ91001, WX9F71001, WW5F11001, V44JT1001, V5CDL1001, WB1AW1001, V3TB91001, VT4HD1001, C59AA1, CK3AN1000, B28J31000, B21AV1000, B27D11000, BP7HC1000, BG8HN1000, BE1GY1000, A3CG11000, A2HG11000, A3XGT1000, A2HG31000, A2HGX1000, Y13EJ1000, Y13EG1000, XC3DT1001, XD4B51001, XD4CA1001, XD3HY1001, XD3JL1001, XD3JM1001, XD3JN1001, XD3H81001, XD3JD1001, XD3JE1001, XD3JF1001, W4DKH1001, WR7G31001, WR7G41001, WR7G51001, WR7GY1001, WE9CW1001, WP8H21001, WR3C11001, WE9C31001, WF4EP1001, WP8H31001, WR3C21001, WR3C31001, WR3N71001, WG7KH1001, WP8H61001, WR3C41001, WG7KE1001, WP8H71001, WR3C51001, AY4AJ1000, Z5KF11000, D22CY1, DP5FG1, DP5FE1, DP5FC1, XC4D81001, WJ6B31001, WF8F71001, V1XDF1001, V1LGT1001, V1LGM1001, A2SDL1000, A53JP1000, 173162, E24F81, E24F71, E5FH41, E5FH31, ED9TC1, D88AF1, D88AE1, D88AD1, DW7CX1, BE2HM1000, BE2HN1000, BE2HP1000, Y4XGS1000, YB3B31000, YB3KE1000, D83N31, DD3AA1, C5HCF1, C5HCE1, C5HCD1, BE2HR1000, BE2HS1000, BE2HT1000, V18FR1001, V44B61001, XH8G31001, W4HA41001, XH1EE1001, W36AE1001, W3TLP1001, W2CJ71001, W11EG1001, W1CH71001, WX9F61001, WV6B31001, V44JV1001, V5CDM1001, V4JKK1001, V18FS1001, V44CC1001, B73B21000, Z74CF1000, X5FBG1000, X5FC51000, W5CHN1001, W48AE1001, W48AY1001, W4RH41001, W4RGX1001, W48A11001, WV5HC1001, WJ6B21001, V86G81001, V19EV1001, V16B41001, V16B21001, UW7EM1001, T2KD11001, TR1AJ1001, U4CFH1001, U4CFH1002, V1EDR1001, U4CFJ1001, U4CFJ1002, U4CFK1001, BC6BK4000, CH7BJ1000, CH8J21000, B55LR1000, B55LS1000, B45AD4000, B2YGB1000, B2YGA1000, B2YF91000, B2YF81000, A53DM4000, EN6KY1, DL8B71, FD6JW1, E5VJ41, EN6K11, DL8B81, FE3K81, WG2JV1001, VC5AJ1001, BG5ER1000, BG5ER1000, WX3DF1001, E1RCG1, E1RCF1, D6EKW1, CL1BW1000, ZD6GG1000, U4EES1001, Z75HT1000, Z75HV1000, U1YKN1001, Z64GF1000, AL4FM1000, Z2JCB1000, U2NGB1001, T5RHC1001, DT1KV1, BB6AX1000, A5AHK1000, AK9AL1000, AK9AW1000, AT2AB1000, AT2AA1000, ZB1AW1000, X53CS1000, X2XFC1000, X1JBB1001, XV5BN1001, WX3GR1001, WX3GP1001, WV1CP1001, WA4A81001, V5JBK1001, U4NC41001, UT8L21001, UT8L21002, UT8L11001, UT8L11002, UT8LY1001, UT8LY1002, VL3EM1002, VL3EM1002, UT8LX1001, UT8LXA001, UF1ER1001, W62AS1001, Y6BGX1000, Y1KAE1000, X2EE81000, WK1JA1001, WG7GB1001, US6AE1001, UK6KL1001, UK1GY1001, TJ6C91001, 173078, A2EHR1000, Y33B81000, YS9GM1000, XT8B41001, D3VK91, FP9AK1, FP9AW1, B5HJ91000, BX8BJ1000, Y2JB51000, WL5DK1001, WL5DJ1001, Y2BFJ1000, TF1D61001, C5SEN1, C5SEM1, FA5AA1, E58R71, E5CLF1, EX6BN1, EJ7RJ1, EJ7RH1, D48HF1, D48HE1, B59E11000, B4LJ41000, B3XGS1000, AR9G11000, AR9GW1000, AR9GR1000, Z71JJ1000, AC1B41000, AC2DX1000, ZF1AK1000, ZF1AR1000, Y4FEV1000, Y33DP1000, VY9AB1001, Z48AA1000, ZY8AN100, X34EN1000, U1PHH1001, VG5G31001, U3WAC1001, UG1GA1001, T6CBA1001, Z1VGL1000, Z1KH51000, W2TD31001, U5HBC1001, U2XBH1001, TX1AL1001, D3FFX1, X3RFV1000, U1NF81001, VK9EK1001, A3EB21000, AB8JE1000, WB6B31001, C2TAB1, A4NAA1000, U74DR1001, C23AA1, B4NAN1000, BT8C61000, BA4F71000, A72D51000, A56KC1000, AR1AH1000, W41AB1001, W3TLX1001, D91CJ1, DH4AK1, AE2HF1000, Z13A51000, YH1EW1000, YG8H91000, X98ET1000, X5PFK1000, W1VJ31001, W1REY1001, V2GEV1001, VP2AB1001, UC6A71001, T96B11001, T4GFF1001, T3BC51001, D3VLD1, DW7AB1, DN6B51, E5LA71, E5LA71, C51F21, C4KHK1, Z5JFB1000, YS5HX1000, YF5G11000, X98EE1000, WB7HJ1001, VC5D61001, U4LJC1001, U34KC1001, UY1F61001, UT1FY1001, UT1DK1001, UH3N51001, UB3EK1001, B52HD1000, TT3ET1001, ET6AM1, D47AB1, DX6AD1, CG4DS1000, B5RCB1000, B1AMH1000, BE2H31000, A3LJC1000, ZA5BJ1000, Y75FF1000, Y5RCK1000, Y5RCP1000, Y41AR1000, Y4PAM1000, YE6HK1000, X1VF81001, XW3HG1001, W91DF1001, W5FC71001, V4VCG1001, V4EFJ1001, VP9DV1001, VP9D61001, VJ4GP1001, T5RHN1001, A6ABV1000, W91DG1001, W53F51001, Z2FD2100, E79AA1, CW2LD1000, WL4FS1001, VH2MK1001, TW2FA1001, W53F61001, E4GE41, W2DC31001, CD3HH1000, A3NCJ1000, X53AT1000, X4YBW1000, WC5H31001, VD5FB1001, FB8D41, EP3HP1, EH1FK1, 112798, D83H11, C33BG1, CD3HK1000, B61AA1000, ZG8FC1000, Y48GF1000, YC4JM1000, W27F51001, W3WGL1001, W3WGM1001, V2YCC1001, 167274, 104475, Z4XEJ1000, C26AA1, Y5VB61000, YR9EP1000, W1VKB1001, YK1G11000, YG7E11000, X3WBC1000, WW3H21001, V36LR1001, V25CB1001, V25CBA001, W5FEN1001, 136076, D5LK11, DR1HV1, DG2C11, A3RD61000, A1SBD1000, YK8J91000, X83KV1000, XW5AT1001, WK4FB1001, WJ1HN1001, V17EB1001, VE4DR1001, VA4BY1001, UX2GK1001, UT1HH1001, UL6CC1001, UE2AC1001, TW2FB1001, TP3BB1001, S5RAL1001, DK3E31, A2RD51000, Y4EED1000, W2DC21001, WW3C21001, WK4FC1001, U4TML1001, UY7HN1001, UX2GT1001, UH4AL1001, UC1LE1001, UC1LG1001, T5RG81001, T4FAE1001, UL5AA1001, C51FY1, DK3N71, ZS5AY1000, U3CAE1001, T64KD1001, DG2FR1, VS2JE1001, T55JH1001, C4PHD1, T54HB1001, ZC9AX1000, VN4BX1001, U3YEF1001, BF6BR1000, 122829, EE3MS1, CG9CJ1000, X1NE71001, 148478, E5WPS1, E5FBA1, DW7CV1, DL3PN1, CF8MH1000, CK4HJ1000, B2CKK1000, B2CKH1000, CL5EJ1000, CL5EX1000, Z5FJB1000, 161235, 168703, 127105, 108010, 102840, FH5N11, FC7M91, E5FBF1, E5FBE1, EW8EC1, EV3KY1, CT8HD1000, CT8HF1000, B85HP1000, B85HN1000, B3DGF1000, B4AC11000, YL1E71000, CT8HE1000, W4SCA1001, E41GJ1, Y37HC1000, B24EN1000, B24EP1000, D3ACD1, A1NAP1000, X48G21000, XE5A71001, U2GAN1001, U16BD1001, U16BE1001, U16BF1001, UY3LM1001, UY3LN1001, UW8BH1001, UW8BJ1001, UW4DX1001, UW4D41001, UW4EA1001, UW4EE1001, UW4EH1001, US7FV1001, UR7KC1001, UW6FA1001, UH5GA1001, UH5GB1001, UH5GC1001, UG8CD1001, UG8CG1001, UG8CL1001, UE5DT1001, UC1BN1001, UC1BR1001, UA7FD1001, UA5HK1001, UA5F31001, UA5F61001, UD1KM1001, E5LC31, 150395, CV6C91000, 123269, 105378, FG9KD1, E83BS1, EP2ND1, FL8DW1, DS6BD4, TL9AJ1001, VP8F21001, T2VC11001, U3XFF1001, UA3FJ1001, VD5BJ1001, CW8CE1000, W26B71001, WA4DL1001, TN4MC1001, T5KBJ1001, T5KBL1001, T5KBM1001, DF3J11, C4FHE1, CT7E31000, CW9JC1000, B4KGM1000, AC9F31000, UT4GC1001, U5CF41005, UT4GN1001, UT4GN1002, UT4GP1001, UT4GP1002, D1SEH1, D1SEK1, EW2BD1, DX9AG1, DX9AG1, DW7HX1, DW7HX1, C59K31, Y6CB51000, Y36BH1000, VV7FY1001, DH3ML1, EW2BJ1, D67DB1, D42AT1, DX9AH1, DX9AH1, DW7H11, DW7H11, DX8JX1, DV5NY1, DH3MJ1, C59K41, C59KY1, BG5FF1000, Y36BJ1000, EW2BL1, D67DD1, DX9AJ1, DX9AJ1, DW7H41, DW7H41, DX8JY1, DV4HH1, DH3MM1, C59K51, C59K11, BG4HX1000, ZC1EL1000, EL1MF1, D67DE1, DX9JS1, DJ1NY1, C59K21, YA9CB1000, V2YE21001, B24GH1000, WT9EX1001, V69H81001, V69H81001, V79DG1003, V79DG1003, A2NGH1000, Y4EFM1000, Y32AG1000, V69H91001, V69H91001, V79DJ1002, V79DJ1002, V79DJ1003, U1RCV1001, ER8AH1, B5JH31000, B11GF1000, BH5JL1000, X1NAY1001, WW2BM1001, VJ9JE1001, VJ9JE1002, VJ9JE1003, VJ9JE1004, VJ9JE1005, VY2FD1001, VJ9JF1001, VJ9JF1002, VJ9JF1003, VJ9JF1004, VJ9JF1005, C1JHB1, VJ9JG1001, VJ9JG1002, VJ9JG1004, VJ9JGA001, VJ9JH1002, EL1MG1, BD2KJ1000, ZK9AL1000, ZP9AA1000, VH9LD1001, VH9LD1002, VH9CW1001, BF8EA1000, A38DM1000, AK9GH1000, X5PFC1000, FK3B31, D67FM1, X5PFG1000, FK3B61, D67FP1, D4RH21, D3FEX1, C48GX1, A4BBN1000, A2YJH1000, A2YJJ1000, Z78GE1000, A2HCL4000, ZX7AA1000, Y3TD71000, Y3TFC1000, ZT3EE1000, Y3ACW1000, YS9F41000, YH9AE1000, YH9AF1000, X44F81000, W98D51001, W98D61001, W25EW1001, UX9J11001, V1DE91001, VT9DV1001, U11HX1001, TF2FY1001, Z19AV1000, CN3G71000, X5ACJ1000, V3NG21001, V3NHH1001, V3NHH1002, V3NHA1001, V3NHA1002, V3NHM1001, V3NHM1002, X5ABP1000, V3NHR1001, V3NHS1001, T3FGD1001, D1TFE1, U31EY1001, U31EY1003, U31EY1004, U31EY1005, U31EY1006, U31EY1007, U31EY1008, U31EY1009, U31EY1010, A73CT1000, U31E21001, U31E21004, A73CE1000, UH5A31001, UH5A41001, U1PEJ1007, U1PEJ1008, U1PEK1002, U1PEK1004, U1PEK1005, U1PEK1007, W4CG21001, WS8AA1001, U1PEL1001, U1PEL1005, U1PEL1007, WS8AB1001, U1PEM1004, U1PEM1005, U1PEM1008, 162804, FJ2FF1, FJ3L51, FF9RM1, FF3GY1, FF3GX1, E87JM1, E5WND1, E48LB1, E4SHH1, E4LPY1, E3JM21, FL8KR1, E3JM11, E28A41, E28A11, E27SS1, EX5FH1, E1HFY1, EV5C71, ET6AB1, ET6AC1, ET6AD1, ET6AA1, EP3HN1, EH6CA1, EF4NL1, EF2CT1, D59SE1, D59SF1, D5AKE1, D4GL21, D32D11, D2SJD1, D3BLN1, D1XKC1, DY7BK1, DR2FB1, DH2BF1, DH2BH1, DE1H31, DE1HY1, DC5KK1, DC5K31, C57A21, C5HEF1, C43KF1, C43KG1, CX1DS1000, CX1CL1000, CH9G11000, CW8AV1000, CA7AN1000, B5CHR1000, B37AB1000, B4CAV1000, B18FC1000, BV1E91000, BV1FA1000, BV9C81000, BV1E81000, BH6EB1000, BB7GB1000, A5EAA1000, A25B21000, BX2EL1000, A2RE71000, AY1D31000, AN3E81000, AN3E91000, AH5JB1000, Z78GD1000, Z55A41000, Z3PFX1000, ZY8AE1000, AT8HC1000, Y89BW1000, Y89BF1000, Y1KB51000, YL8BJ1000, YH8EC1000, YE6FJ1000, X3SHD1000, X3LE11000, X1XB11001, X1PDB1001, XT2HG1001, XN8HN1001, XJ7FW1001, XE5FL1001, XF3JJ1001, W6EH71001, XL3BC1001, WV6D91001, WK5DD1001, V94AC1001, WK5DG1001, U2RDM1001, U11A31001, U11A41001, TH7EA1001, TH2AA1001, T46LJ1001, T46LJ1002, UE6B61001, VS2FV1001, Z19F91000, WD3CB1001, V4JKY1001, V42HH1001, U2SEX1001, V5KGW1001, VD3FJ1001, U5DEC1001, VY8EW1001, UJ2FE1001, T5CPT1001, T2HJC1001, T2RF41001, T2RF91001, W3VKV1001, W2CFS1001, W2CFM1001, W2CHK1001, W2EBL1001, W2EBL1002, W2BGF1001, UX9FP1001, VN3FB1001, US7FR1001, UN5B21001, UN5D91001, T5XCJ1001, UW8D71001, UT3D11001, UN6A51001, US7FS1001, VF1GX1001, VF1GY1001, UW8EB1001, UT3D51001, U55DJ1001, U55DK1001, U55DL1001, U55DN1001, U55DP1001, WD8DJ1001, TH5M11001, YF9F51000, YF9GE1000, XA8GA1001, XA8GB1001, W39G61001, Z5WD41000, Z5WD31000, X1XCC1001, X1XCD1000, AK1FN1000, XP7C41001, XP7C61001, W3DAN1001, WL6DH1001, W39G71001, U5KJL1001, AK1F91000, AK1GB1000, YF9GL1000, XY4K11001, TV1AK1001, TV1AL1001, YT3AB1000, YT3AC1000, XJ1A21001, XJ1A31001, XJ1A41001, XA8GC1001, XA8GD1001, W58FY1001, W58F11001, W58F21001, W39G81001, W3VHJ1001, WL4DW1001, U36EH1001, U4KFA1001, UY4BD1001, 125938, ES7AA1, EL1LM1, C1VKA1, CS2J21000, BB9GW1000, A6ADD1000, AN4DR1000, AP3G91000, V49HT1001, VV2BE1001, UV1BN1001, A12GK1000, A86GW1000, AJ8DH4000, Z5FH51000, YX5FS1000, W62AB1001, V4LE61001, V4AAC1001, VY7FN1001, VX3BB1001, VC8EF1001, UG6K91001, W24KT1001, WB1ES1001, C56EC1, T97HF1001, TY4D21001, CR2C51000, XE6HX1001, DW3DP1, UT3DN1001, T4NJE1001, Y46H71000, X1VDB1001, UK7GE1001, 131074, 111197, FC6L11, ES7AB1, EL1LL1, EA5K61, D88FT1, D47MN1, D3AH21, D3HLT1, DR5L61, DR5L51, DR9GD1, DR9GC1, DF9EX1, DF9EW1, C56EB1, C56EA1, C4BE71, C4BE61, C1VKC1, C1VKD1, CV7BK1000, CV7G21000, CT2ML1000, C4AH41, D88FV1, D3HHT1, DR9GB1, X4KE71000, WF6DK1001, V4AAD1001, VA2KD1001, U4FDL1001, UR8DN1001, UJ2DXA001, T4FAF1001, YX7E21000, W5VAW1001, CV5DM1000, TS2AN1001, Y1TAA1000, Y1TAB1000, Y1TAC1000, Y1TAE1000, X61FD1000, V71G91001, U34BM1001, X68GL1000, X68GM1000, X68GN1000, X68GP1000, X68GR1000, X5EJ91000, E5RHK1, DG1AS1, CA4P21000, B61BS1000, B36K11000, BY6AL1000, BY2GD1000, BK8G81000, BK7EF1000, A43HP1000, A4EBG1000, A3GDY1000, A1YG11000, A1JFB1000, AG5B11000, Z88GS1000, Z66H31000, Z74K71000, Z2YD61000, W77DP1001, W4RGY1001, XX3F91001, 124497, 119575, 104698, 101933, FG7M61, FC6MM1, EL6HR1, D85FS1, Z74HV1000, W1YGX1001, B5TAP1000, Z67F71000, XN8BC1001, E74MX1, DD9BW1, E28J91, CH3AA1000, AC8EA1000, AC8D91000, ZY8AD1000, ZT9AC1000, ZL6CJ1000, ZJ3AA1000, ZH6AR1000, Y4SJR1000, YH8HJ1000, YB3DM1000, X58BA1000, XW8B91001, XF3JM1001, X5SGW1000, XF5FR1001, XB7GL1001, W61AB1001, W5FEF1001, Z46EN1000, 108430, E5LNK1, D65AA1, AC9FV1000, Z78GC1000, AD3HF1000, Z46AA1000, Z3DA41000, Z3HAA1000, Z2RAA1000, Z1HF11000, ZW9A61000, ZT5EX1000, ZV1AD1000, ZS8JA1000, ZN3H21000, Y6CAE1000, Y64BK1000, Y42EY1000, YW8GS1000, X43A51000, X3WBK1000, ZL7FK1000, ZD1JW1000, XV4G31001, XF6CA1001, XJ5J21001, XA3E41001, W57KF1001, WJ2JS1001, ZF7AR1000, FH5MA1, D2KA81, D2LKL1, DE4JT1, A71F31000, A34BW1000, Z82KN1000, Z4EE21000, Z2SAT1000, ZR7JF1000, ZR3DF1000, Y81AR1000, Y82AC1000, Y3YFT1000, ZH5GF1000, X44EJ1000, X44AA1000, WH1PX1001, WC3LE1001, V78GW1001, V59GA1001, VW4GL1001, D4BLH1, AP7AB1000, ZR3DK1000, Z46AB1000, XB7GN1001, FN5EE1, FN5ED1, FN5EB1, E4SHL1, E4SHK1, E4SHJ1, DB5LF1, A5EJE1000, AK2FK1000, YS5JN1000, V3CEC1001, 136991, FJ3AH1, E3BVB1, E2AAB1, EK9EB1, EP6RD1, EH9N21, D3RJ61, DW1BG1, DF9J71, DF9J61, DH2AW1, DC8C21, CP6HX1000, CC7D51000, B3FA51000, B25FV1000, AY3FX1000, AV7GD1000, AJ4F61000, AH6GA1000, AH6F91000, Z75GM1000, Z72C91000, Z56AB1000, Z6AAA1000, Z5XGT1000, Z4XFJ1000, Z32AF1000, Z1YJM1000, ZY2G81000, ZY5GY1000, ZT9B81000, ZT2BW1000, Z44EP1000, ZS6AN1000, ZK1FJ1000, ZF1EE1000, ZF1EG1000, ZC7FG1000, ZB4G21000, ZA6BR1000, Y55H71000, Y5EE91000, Y3RD91000, Y28J91000, Y2FAJ1000, YW9DL1000, YV9AD1000, YS5G71000, YL9EP1000, YP5DK1000, YP2D11000, YE4K21000, YA8AW1000, YN8D91000, X35BM1000, X85CS1000, X77CR4000, X83AB4000, X14F11001, X2JF11000, XH7JD1001, XE2F71001, W53BX1001, W5FEJ1001, W5CAA1001, WE6M11001, AF3AC1000, BB3AA1000, BA8DN1000, AY8BT1000, AW1AB1000, AV2EK1000, AT3GM1000, AT5FG1000, AS7HN1000, AN9HR1000, AN5A21000, AG4FG1000, AE3GY1000, AE3FG1000, AH3AM1000, AH3A31000, AH3AR1000, AC5H61000, AE1HL1000, AA9AS1000, AA5GN1000, AA4F41000, AF3E41000, Z89D51000, Z81AC1000, Z87FG1000, Z67DD1000, Z67DC1000, Z63CA1000, Z57EA1000, Z54AA1000, Z5PGW1000, Z5FHK1000, Z45HM1000, Z4YJB1000, Z4EBA1000, Z35DC1000, Z3NB31000, Z2NAC1000, ZY9H71000, AH6GB1000, AB3FY1000, Z83AA1000, Z5LFK1000, Z41H21000, Z3EAG1000, Z2NAB1000, Z13F31000, Z14AA1000, Z1VE81000, Z1RE61000, Z1GGL1000, ZY3AA1000, 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T4SAA1001, T4WAT1001, T4ECB1001, DW7CW1, WP1BM1001, TR8DB1001, TC1GK1001, TC1F21001, UG6J31001, TW9EP1001, VS6BC1001, TH5JA1001, YV1HT1000, UC6KB1001, UC6KH1001, UC6KN1001, UY7GR1001, UY7GV1001, BD3AH4000, T46LL1001, T46LK1001, T83AJ1001, TT6GT1001, VE9HP1001, UK1GS1001, UK1GX1001, Y68AW1000, WD1BB1001, XJ1AR1001, XJ1AS1001, DP5GG4, TH7AB1001, TH7AA1001, Z53JX1000, BR7F7100, ZV3DS1000, C3AB81, D5GDT1, A29F61000, V2CB51001, U54HA1001, UN9J51001, ZF7KL1000, D73KL4, D73KM4, D5LM34, D5LM24, AK9EA1000, YH9AD1000, XF4DW1001, XF4DX1001, 114413, 113505, D3FCW4, DB7C54, DB7C14, DR2HF1, DR2HE1, DS2EB4, D83M91, D5GDV1, D1LAA1, C3AB91, B5SC81000, BR7F81000, A22G91000, Z5VAD1000, Z65B21000, B5BA54000, B2YEH1000, AX3AA1000, Z66FV1000, ZW5CC1000, Y3GFL1000, X91D91000, ZF7KM1000, YK3GY1000, V5DEF1001, V5DEF1002, WD1KE1001, WE7BF1002, WL6EV1002, V5DEJ1001, V5DEJ1002, V5DEJ1003, V5DEJ1004, V5DEJA001, WD4E91001, WD4E91002, WD4E91003, WD4E91004, V2VHE1001, V3KGH1001, V3KGH1002, V3KGH1003, V3KGH1004, V5DEK1001, V5DEK1002, V5DEK1003, V5DEK1005, WD1JT1003, FN6C84, E1RKM1, D58L41, D4HLH1, D4HLF1, D3HFD4, DR3J61, C2EAA1, BB3GY1000, ZT9JM1000, Y49CD4000, X2SA54000, WJ1MB1001, WJ1MA1001, YL8GK1000, 120360, DX7K71, E5EBM1, 167405, E5EBL1, E5FEW1, C4RAG1, C3VJR1, B4VG81000, B5JD61000, B5JD51000, BV7F11000, 118811, D6DJA1, X2JCR4000, WH9JB1001, 161847, FF1AC1, E65LB1, EY5J51, CB8GW1000, FD8AB1, FD8C31, E87B71, FD6JH1, E68B21, E56M11, E3JMY1, E29LS1, E1KMF1, E1KMD1, DE6LM1, D2DBM1, C5PBE1, C3RB61, CS4JY1000, CS1EK1000, CF5AW1000, CG3HY1000, 162795, 160716, 153128, 157312, 136994, 133508, 135555, FJ3LT1, FD8AA1, FD8C21, E87B61, E68B31, E68AA1, E56MY1, E29LR1, E2JHG1, E1KME1, E1KMC1, EY5AA1000, EN1AA1, EE4KN1, D89AK1, DV3AA1, DL2KM1, DG9KW1, DG1P71, DN1K11, DC2D81, 131511, 131508, 131466, 137087, C78BK1, D1XGF1, D1XGD1, DL3PL1, 162613, 164053, 159953, 162617, 162799, 155603, 139464, 146549, 130351, 142253, 112954, 135032, FP2AD1, FK8LN1, FJ9HN1, FJ9HP1, 140096, FJ5JM1, FH6ES1, FF3KR1, FF1AD1, 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WB2JM1009, WB2JM1010, XF5FM1001, XA7FL1001, W84HN1001, W84HR1001, VK7F61001, 154044, 148531, 129317, 122912, FJ6AN4, FH7A84, E97JN1, E57D81, E13GK1, ER2EL1, ED6PD1, D91EK1, D74LX1, D6CK41, D52PH1, D3CLK1, D32A71, DF5AC1, DC5AA1, C82MM1, C66GA1, C6DF11, C4TL61, C42E11, C4FH11, C3VE51, C29FF1, C3BGR1, EE6LT1, C2LH11, C17L91, C2BDP1, C1NBL1, C2CJJ1, C13C71, C3DCT1, CY4DC1000, CR3LR1000, CK6JJ1000, CK4HK1000, CC7RD1000, B5WDE1000, CH4NF1000, B96CG1000, B5JA64000, B4DFS1000, B5CBV1000, B1WG61000, BT1HY1000, BT4B81000, BV6GK1000, BR4CN1000, BN4C51000, BL4BY1000, BG8CG1000, BH3AS1000, BL5E21000, BK7BS1000, A82L71000, BB6J91000, CH2CH1000, A5SG21000, A95AR1000, BH3F71000, A3RFX1000, A3XAA1000, A4LA71000, A2WG51000, A2LAM1000, A1JGJ1000, AV2C31000, AX6F81000, Z96CA1000, Z5WFF1000, Z4CEB1000, B5CBB1000, Z5JFF1000, B3VGG1000, B1PAA1000, BJ3HD1000, Z1KHK1000, ZY3C81000, AR6DE1000, ZX7HN1000, Z1RH81000, ZY3GS1000, ZR3JT1000, ZF2HX1000, ZD4DA1000, ZK8C51000, ZF4H71000, ZB2AL1000, Y65E91000, 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W2DB54001, WX2GS4001, WX2GM4001, WX2GH4, W2LBL4001, WX2GC4, W2DBJ4001, W2DBN4001, W2DBT4001, W2DB24001, W2DB64001, WX2GT4, WX2GN4, WX2GJ4, WX2GE4, WX2GB4, W2DBK4001, W2DBP4001, W2DBV4001, W2DB34001, W2DB74001, W14AK4001, WX2GP4, W2LBM4001, WX2GF4, W14AL4001, W2DBL4001, W2DBR4002, W2DBW4001, W2DB44001, W2DB84001, WX2GW4, WX2GR4, W2KA64001, WX2GG4, WX2F94003, T3SBE1001, T3SAW1001, BY6AA1000, UK6NB1001, UK6NC1001, FL2WF1, BW7AA1000, BW7AB1000, BT8E21000, BV2EF1000, BV6AA1000, BV6AC1000, BV6AD1000, BV6AE1000, BV6AG1000, BV6AF1000, A3FEB1000, A3FEC1000, A3FEA1000, A3FD91000, A3FD61000, A3FD71000, A3FD81000, A2HBF1000, A2HBH1000, A2HBK1000, A2HBN1000, AV2EL1000, AV3AG1000, AV7HX1000, AV7HY1000, B1XDD1000, BA5MV1000, ZJ9L74000, W3SB54001, 245412, 196717, 196718, 196653, 196654, A4CBA4000, WV7BP4001, WE1AA4001, Y2AE94000, X27AB4000, W5FE21001, US6D31001, D3GJT1, YY6FK1000, X2LJW1000, AX5CS4000, AG8DE4000, ZR4AD4000, VY8A74003, UV2CE1001, UB2CA1001, YR2BR1000, UB2CB1001, UD1KN1001, V25CG1001, X3BA44000, VW3CS1001, UP7AJ1001, AB1AS1000, U34AY1001, EW7LM1, EW7LL1, AE9ET1000, Z41AW1000, Z2RCB1000, Y1JFV1000, WN1DA4001, V17EC1001, VA9GD1001, U2WJV1001, UY3K51001, T3TEM1001, VL3HF1001, YC2HF1000, WG4FF1001, U2WJ11001, UY3K81001, CR5F51000, B85HH1000, WG4FL1001, U2WJ31001, TT7D31001, Z4GHW1000, Z38AE1000, Z38AC1000, XD2BL4001, XD2BM4001, W4WA14001, 197052, 197053, DW8FT1, 167644, FH1T31, Y73HL1000, 162899, T3HA21001, B4EJM1000, B4HYJ4000, B4HYK4000, B4HYL4000, B4HYN4000, B4HYM4000, B4EJL1000, W2LDD1002, W2LDF1001, W2LDK1001, W2LDL1001, W2LDM1001, W2LDN1001, W2LDP1001, W2LDV1001, V63J81001, V63KA1001, V4HA31001, V4BBE1001, V4BBE1001, V4BBE1002, V4BBE1002, V33CP1001, V33CP1001, V4WGS1001, V4WGS1001, V33CN1001, V33CN1001, V4WGR1001, V4WGR1001, V33CL1001, V33CL1001, V4WGP1001, V4WGP1001, V33CK1001, V33CK1001, V4WGN1001, V4WGN1001, V42FV1001, V42FV1002, V42FV1002, V4KAR1001, V4KAR1002, V4KAR1002, V34DD1001, VJ4CH1001, A5NK71000, A5EJD1000, U4PDF1001, EC3AC1, VJ9B31001, Z3DG71000, ZT3E71000, U5LFJ1001, U5TCS1001, U5TCX1001, U72E21001, U72EY1001, U5LFD1001, U63B91001, U72EW1001, U53D51001, U53EB1001, U5EA71001, U5BBB1001, U5BBC1001, U5EGR1001, U5EA81001, U5BBA1001, U5BA51001, U5EA51001, VV9HB1001, VJ9CJ1001, U5TCY1001, U72E41001, U72E11001, U5LFF1001, U81A71001, U72EX1001, U53D61001, U53ED1001, U5LFK1001, U5TCT1001, Z2TK81000, WJ8GL1001, FG9C51, W3LEL1001, VE8BT1001, UD4KH1001, T51CF1001, E1HEG1, A4BCL1000, AK2FJ1000, AK2FH1000, YV3AG1000, VE7DS1001, VE7DS1002, VE7DS1003, U46CR1001, U4BBK1001, U4BBK1002, W39KE1001, U5DD71001, VE8BV1001, U4TN51001, U37AB1001, U17BE1001, UV7AT1001, UA4GP1001, T51CG1001, T5XFP1001, DX8J31, A3CG21000, Z45G31000, Z2NG51000, Y75B91000, YC9GP1000, XB5BH1001, VE7DT1001, VE7DT1002, VE7DT1003, U46EA1001, U5TC21001, U63E71001, U63E51001, U5LFG1001, U63CA1001, U63CK1001, U53D71001, U53EF1001, U5LFL1001, U5TCV1001, U4BBJ1001, U4BBJ1001, U4BBJ1002, U86AA1001, U86AA1001, V1EC41001, V1EC41002, U37AD1001, U17BF1001, UV7AW1001, UR7JL1001, C6EHW1, AH7F91000, VR1FE1001, E75LJ1, E75LG1, XD4B71001, WB1AB1001, VW7KV1001, VE7DV1001, VE7DV1002, VE7DV1003, U2FCX1001, U19G21001, YE8FG1000, X1PDG1001, XR4E81001, WP1B41001, V1AAL1001, VV9HC1001, U37AC1001, U17BG1001, U17BG1001, UW8E71001, UW8E71001, UA4GR1001, D4AJH1, B94AG1000, A2EGJ1000, XW3GJ1001, VX9E61001, VT8BS1001, U5TC41001, U63E81001, U63E61001, U5LFH1001, U63CD1001, U63CL1001, U53D91001, U53EJ1001, U5LFM1001, U5TCW1001, U5EBA1001, U5EA31001, U5BBG1001, U5BBF1001, U37AE1001, U17BH1001, UW8EW1001, AY3A31000, T74GA1001, 105099, DX8J21, Y1CFA1000, VY7CL1001, VY7CL1001, VY7CL1002, VY7CL1002, V1AAM1001, W36AA1001, W36AB1001, T14AB1001, 196024, U71FT1001, UX9BE1001, 196728, 195849, WK5B24001, WX7B84001, WE9CC4001, T5XFB1002, T55DL1001, UA6CE1001, UA6CD1001, T55AK1001, T55AL1001, W5HAF4001, W5HAG4001, T5KJ61001, T3PGB1001, T33D81001, T73CA1001, T73CA1002, VD4DS1001, T73CX1001, T73CX1002, VC7CS1001, T73C71001, T73C71002, T73DK1001, T73DK1002, V5CAV4003, X22CD4000, WP7E51001, V5HBH1001, WP7E61001, WP7E71001, WP7E81001, T82CE1001, T82CF1001, W2JGD1001, WC6C34001, WC6C24001, T3BCK1001, T56C11001, T5VE31001, T3BBD1001, T56C91001, T56C91002, T56C91002, T5VF31001, T5VF31002, T3BBE1001, T56DC1001, T56DC1001, T56DC1002, T5VF41001, T5VF41002, BF6BW4000, BF6BX4000, and W4RA94001. Class II In connection with a Warning Letter received from the U.S. Food & Drug Administration on December 9, 2011, DePuy Orthopaedics is taking steps to retrieve custom device implants that surgeons may have ordered from DePuy Orthopaedics, but not implanted. DePuy Orthopaedics received a Warning Letter from the FDA on December 9, 2011 regarding custom device implants. DePuy Orthopaedics has discontinued supplying custom device implant products in the U.S. The Agency has identified concerns about DePuy Orthopaedics interpretation of the custom device definition. In addition to requesting that DePuy Orthopaedics notify surgeons that FDA has concerns about DePuy Orthopaedics interpretation of the custom device definition, FDA has requested that the company also take steps to retrieve custom device implants that were ordered from DePuy Orthopaedics, but not implanted. DePuy Orthopaedics, Inc.
Food Crispy Just Baked Punjabi Cookies 800g, 14 cartons/case. No codes. Class I In response to firm's supplier recall in Canada and CFIA's allergy alert for undeclared milk in certain 800 g crispy just backed Punjabi cookies. Shah Distributors, Inc
Food Brand name is Yatta. OYSTERS 1/2 SHELL 144CT, PRODUCT OF KOREA Item No. 5400100 Class II The product has been prpared, packed, or held under insanitary conditions wherby it may have become contaminated with filth, or whereby it may have been rendered injurious to health. Icrest International LLC
Food OYSTER MEAT IQF LARGE 5/4 LBS PRODUCT OF KOREA Item No. 5400100 Class II The product has been prpared, packed, or held under insanitary conditions wherby it may have become contaminated with filth, or whereby it may have been rendered injurious to health. Icrest International LLC
Food OYSTER MEAT IQF 6/5# LBS KR PRODUCT OF KOREA Item No. 5410110 Class II The product has been prpared, packed, or held under insanitary conditions wherby it may have become contaminated with filth, or whereby it may have been rendered injurious to health. Icrest International LLC
Food OYSTER MEAT IQF TINY 40/8OZ PRODUCT OF KOREA Item No. 5410120 Class II The product has been prpared, packed, or held under insanitary conditions wherby it may have become contaminated with filth, or whereby it may have been rendered injurious to health. Icrest International LLC
Drugs Topiramate Tablets, 50 mg, 30-count (3 x 10) unit-dose blisters per carton, Rx only, Mfd by: Cadila Healthcare Ltd., Ahmedabad, India; Dist By: Zydus Pharmaceuticals USA, Inc., Pennington, NJ 08534, Pkg by: American Health Packaging, Col. OH 43217, NDC 68084-343-21, blister barcode 6808434311 Lot #: 113032A, 113032B, Exp 04/13 Class III Labeling: Label Mix-Up: A typographical error in the product form on the carton label incorrectly lists the configuration as 30 "Capsules" (3 x 10) rather than "Tablets". American Health Packaging
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