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U.S. Department of Health and Human Services

Enforcement Report - Week of May 7, 2014

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Product Type Product Description Code Info Classification Reason for Recall Recalling Firm
Biologics Red Blood Cells Leukocytes Reduced 016GP31723, 016GR23006, 016GR23009, 016KC33607, 016LG80024, 016LG80027, 016LG80028, 016LG80029, 016LG80031, 016LG80032, 016LM85273, 016LM85279, 016LM85280, 016LM85290, 016LM85302, 016LM85304, 016LZ27715, 016LZ27727, 016LZ27733, 016LZ27734, 016GS28568, 016GX19054, 016GX19068, 016GX19069, 016GX19077, 016GX19089, 016GX19090, 016GX19099, 016KJ21807, 016KJ21809, 016KL01879, 016LH87692, 016LH87698, 016LQ40022, 016LQ40023, 016LQ40024, 016LQ40026, 016LQ40027, 016LQ40032, 016LR77771, 016LR77774, 016LR77778, 016LR77785, 016LR77787, 016GX19081, 016GM47498, 016GQ25044, 016LW71414, 016LW71415, 016GJ37237,  ...
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Class III Blood products, which may have reached unacceptable temperatures during shipment, were distributed. American National Red Cross
Biologics Cryoprecipitated AHF 016GX19419, 016LC29235, 016LG79568, 016GM46776, 016GX18130, 016LG78306, 016LC28864, 016LH86961, 016GM46777, 016GR21510, 016GS27274, 016GY04855, 016KL01652, 016LC28868, 016LG78302, 016LG78305, 016LK21046, 016LK21050, 016LQ39548, 016LQ39577, 016LR77174, 016LW70975, 016GR21515, 016LR74299, 016GP26988, 016GS23835, 016LG73515, 016LG73734, 016LQ37299, 016LR74333, 016GS23895, 016GS23999, 016GW41283, 016KJ17875, 016LR74312, 016LR74410, 016LR74478, 016GW41244, 016LQ37207, 016GP26990, 016GS23981, 016LG73512, 016GX13900, 016GM47400, 016GQ25149, 016GS28603, 016LM84672, 016LM84675, 016LM84680, 016LM84682,  ...
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Class III Blood products, which may have reached unacceptable temperatures during shipment, were distributed. American National Red Cross
Biologics Platelet, Pheresis, Leukocytes Reduced 2485050861, 2485050875, 038FX00758, 038FX00748, 038FX00757, 038FX00754 (2 units) Class III Blood products, which may have reached unacceptable temperatures during shipment, were distributed. American National Red Cross
Biologics Platelets Pheresis, Leukocytes Reduced, Irradiated 050KP02610, 050P43602, 050KP02606, 050P43601, 050P43596, 050KP02615, 050P43599, 050KP02605, 050KP02613, 016KF48111, 016KF48100 Class III Blood products, which may have reached unacceptable temperatures during shipment, were distributed. American National Red Cross
Biologics Plasma, Cryoprecipitate Reduced 016GM46168, 016GR20900, 016LR76746, 016GJ35838, 016GP30057, 016GR20920, 016GS27167, 016GW44234, 016KG12897, 016LG77729, 016LH86570, 016LK20585, 016LP12080, 016LR76720 Class III Blood products, which may have reached unacceptable temperatures during shipment, were distributed. American National Red Cross
Biologics Red Blood Cells 050K41787, 050L23164, 016LT32806, 016LT32807 Class III Blood products, which may have reached unacceptable temperatures during shipment, were distributed. American National Red Cross
Biologics Fresh Frozen Plasma 016LK22501, 016LM85463, 016LR78500, 016GX20022, 016KG14368, 016KJ22339, 016LK22505, 016LK22922, 018FZ55729, 018FZ55730, 018GN44073, 018GX00359, 018FF10591, 018FS93959, 018FW66959, 018FX72618, 018GN43948, 018GR05695, 018GR05697, 018GT03768, 018GT03776, 018GX00350, 016GP31857, 016GQ25586, 016GR23070, 016GR23075, 016GS29174, 016GW45964, 016KG14367, 016KJ22330, 016LR78440, 016LR78475, 016KJ22342, 016LK22576, 016KG14369, 016LH88437, 016LK22521, 016LW71914, 016LW71218, 018GT03858, 018GT03859, 018GT03860, 018GT03863, 018GT03866, 018GT03867, 016LK21195, 016LK21210, 016GP31853, 016GR23060, 016GR23078,  ...
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Class III Blood products, which may have reached unacceptable temperatures during shipment, were distributed. American National Red Cross
Drugs Adipotrim XT, New Powerful Formula, 30 rapid release capsules per bottle, Dietary Supplement, www.adipotrim.com. Lot #: 052012, Exp 10/2015 Class I Marketed Without an Approved NDA/ANDA: FDA lab results found undeclared API Fluoxetine in this dietary supplement. Deseo Rebajar
Devices Medtronic neurostimulators. Restore (37711), RestoreADVANCED (37713), RestoreADVANCED SureScan MRI (97713), RestoreSENSOR (37714), RestoreSENSOR SureScan MRI (97714), PrimeAdvanced SureScan MRI, (97702), RestoreULTRA (37712), RestoreULTRA SureScan MRI (97712), Itrel 4 (37703), Itrel 4 (37704), RestorePrime (37701), PrimeAdvanced (37702), Spinal Cord Stimulators for chronic pain. The first released affected product was released to the market in April, 2005. Class II Medtronic neurostimulators (used with pain and deep brain stimulation therapy) have a cycling feature that, when enabled, allows stimulation output to be toggled on and off based on the programmed settings. The use of this feature is determined by the physician and set using the clinician programmer. Current labeling indicates the use of cycling improves device longevity and recharge interval under all programming scenarios; however Medtronic has identified that in some situations the use of cycling can reduce the device battery longevity or recharge interval. The only impact to patients is the potential for earlier than expected replacement or recharging at a greater than expected frequency. The issue doesn't impact the device end of service alarms. Medtronic Neuromodulation
Devices Medtronic Activa RC (37612), Activa PC (37601), Activa SC (37602), Activa SC (37603), Activa PC+S (37604), Multi-program Rechargeable Neurostimulator for Deep Brain Stimulation for movement disorders. The first released affected product was released to the market in April, 2005. Class II Medtronic neurostimulators (used with pain and deep brain stimulation therapy) have a cycling feature that, when enabled, allows stimulation output to be toggled on and off based on the programmed settings. The use of this feature is determined by the physician and set using the clinician programmer. Current labeling indicates the use of cycling improves device longevity and recharge interval under all programming scenarios; however Medtronic has identified that in some situations the use of cycling can reduce the device battery longevity or recharge interval. The only impact to patients is the potential for earlier than expected replacement or recharging at a greater than expected frequency. The issue doesn't impact the device end of service alarms. Medtronic Neuromodulation
Devices Medtronic, External neurostimulator, ENS (37021) & ENS (37022). Including the external neurostimulators which are associated with software application run on the NVision Clinician Programmer and used during trialing for spinal cord stimulation (SCS) patients. The first released affected product was released to the market in April, 2005. Class II Medtronic neurostimulators (used with pain and deep brain stimulation therapy) have a cycling feature that, when enabled, allows stimulation output to be toggled on and off based on the programmed settings. The use of this feature is determined by the physician and set using the clinician programmer. Current labeling indicates the use of cycling improves device longevity and recharge interval under all programming scenarios; however Medtronic has identified that in some situations the use of cycling can reduce the device battery longevity or recharge interval. The only impact to patients is the potential for earlier than expected replacement or recharging at a greater than expected frequency. The issue doesn't impact the device end of service alarms. Medtronic Neuromodulation
Drugs Cefoxitin for Injection and Dextrose Injection, 1 g in Duplex, 50 mL Container, Catalog No. 3123-11, For IV Use Only, Single Use, Sterile, Rx Only, B Braun Medical Inc, Irvine CA 92614-5895, NDC 0264-3123-11 Lot# H3E507, Exp 11/14 Class I Presence of Particulate Matter: B. Braun Medical Inc. is recalling several injectable products due to visible particulate matter found in reserve sample units. B. Braun Medical Inc
Drugs 0.9 % Sodium Chloride Injection USP in PAB 50 mL partial fill in 100 mL PAB Container, Catalog No. S8004-5384, Rx Only, B Braun Medical Inc., Irvine CA 92614-5895, NDC 0264-1800-31 Lot# J2P912, Exp 02/14 Class I Presence of Particulate Matter: B. Braun Medical Inc. is recalling several injectable products due to visible particulate matter found in reserve sample units. B. Braun Medical Inc
Drugs Ceftriaxone for Injection and Dextrose Injection, 1 g in Duplex, 50 mL Container, Catalog Number 3153-11, For IV Use Only, Single Dose, Sterile, Rx Only, B Braun Medical Inc., Irvine CA 92614-5895 Lot# H3B702, Exp 02/15 Class I Presence of Particulate Matter: B. Braun Medical Inc. is recalling several injectable products due to visible particulate matter found in reserve sample units. B. Braun Medical Inc
Drugs Cefepime for Injections USP and Dextrose Injection USP, 1 g in Duplex, 50 mL Container, Catalog Number 3193-11, For IV Use Only, Single Dose, Sterile, Rx Only, B Braun Medical Inc., Irvine CA 92614-5895, NDC 0264-3193-11 Lot# H2L712, Exp 09/14 Class I Presence of Particulate Matter: B. Braun Medical Inc. is recalling several injectable products due to visible particulate matter found in reserve sample units. B. Braun Medical Inc
Drugs Cefazolin for Injection USP and Dextrose Injections USP, 1 g in Duplex, 50 mL Container, Catalog Number 3103-11, For IV Use Only, Sterile, Single Dose, Rx Only, B Braun Medical Inc., Irvine CA 92614-5895, NDC 0264-3103-11 Lot# H2S725, H2S726, Exp 07/14; H3D724, Exp 11/14; H3E724, Exp 12/14; Lot# H3H507, Exp 01/15 Class I Presence of Particulate Matter: B. Braun Medical Inc. is recalling several injectable products due to visible particulate matter found in reserve sample units. B. Braun Medical Inc
Drugs Cefazolin for Injection USP and Dextrose Injection USP, 2 g in Duplex, 50 mL Container, Catalog Number 3105-11, Rx Only, B Braun Medical Inc., Irvine CA 92614, NDC 0264-3105-11 Lot# H2S723, Exp 07/14; H3H711, Exp 01/15 Class I Presence of Particulate Matter: B. Braun Medical Inc. is recalling several injectable products due to visible particulate matter found in reserve sample units. B. Braun Medical Inc
Drugs 0.9 % Sodium Chloride Injection USP, 1000 mL, Catalog No. S4000-SS, Rx Only, Sterile, Single Dose Container, B Braun Medical Inc., Irvine, CA 92614-5895, NDC 0264-4000-55 Lot# J0B003, Exp 02/14 Class I Presence of Particulate Matter: B. Braun Medical Inc. is recalling several injectable products due to visible particulate matter found in reserve sample units. B. Braun Medical Inc
Drugs 6.9% FreAmine HBC (Amino Acid Injection), partial fill container 750 mL in a 1000 mL container, Catalog No. S9350-58SS, Sterile, Single dose container, Rx Only, B Braun Medical Inc., Irvine, CA 92614-5895, NDC 0264-9350-55 Lot# J2H002, Exp 06/14; J2S018, Exp 12/14 Class I Presence of Particulate Matter: B. Braun Medical Inc. is recalling several injectable products due to visible particulate matter found in reserve sample units. B. Braun Medical Inc
Drugs 15% Amino Acids Injection PBP Glass, 1000 mL, Catalog No. S3200-SS, Pharmacy Bulk Package, Not For Direct Infusion, For Intravenous Use, Sterile, Single Dose Container, Rx Only, B Braun Medical Inc., Irvine, CA 92614-5895, NDC 0264-3200-55 Lot# J2J012, Exp 01/14; J3B002, Exp 08/14 Class I Presence of Particulate Matter: B. Braun Medical Inc. is recalling several injectable products due to visible particulate matter found in reserve sample units. B. Braun Medical Inc
Drugs TrophAmine (10% Amino Acid Injection), 500 mL Container, Rx Only, Catalog No. S9341-SS, Sterile, Single Dose Container, B Braun Medical Inc., Irvine CA 92614-5895, NDC 0264-9341-55 Lot# J3A028, Exp 07/14 Class I Presence of Particulate Matter: B. Braun Medical Inc. is recalling several injectable products due to visible particulate matter found in reserve sample units. B. Braun Medical Inc
Drugs ProcalAmine (3% Amino Acid and 3% Glycerin Injection with Electrolytes) 1000 mL Container, Rx Only, Catalog No. S9050, Sterile, Single Dose Container, B Braun Medical Inc., Irvine CA 92614-5895, NDC 0264-1915-07 Lot# J2K023, Exp 02/14 Class I Presence of Particulate Matter: B. Braun Medical Inc. is recalling several injectable products due to visible particulate matter found in reserve sample units. B. Braun Medical Inc
Drugs Hyperlyte CR (Multi-Electrolyte Concentrate), 20 mL/dose, 250 mL Container, Catalog No. S9432, Rx Only, Sterile, B Braun Medical Inc., Irvine CA 92614-5895, In Canada Dist by: B Braun Medical Inc., Scarborough, Ontario M1H 2W4, NDC 0264-1943-20, Canada DIN 01924311 Lot# J3B007, Exp 08/14 Class I Presence of Particulate Matter: B. Braun Medical Inc. is recalling several injectable products due to visible particulate matter found in reserve sample units. B. Braun Medical Inc
Drugs Human Chorionic Gonadotropin, EP (HCG) in 5 mu. 2 mu, and 1 mu packages, For use and distribution in prescription compounding, manufacturing, processing or repacking only in accordance with FDA regulations and applicable law. Potency 5489.6IU/mg. Packed by Medisca, Inc. Irving, TX, 75063, USA NDC 38779-2673-1, NDC 38779-2673-2, and NDC 38779-2673-6. Lot Numbers 101751/A, Exp: 05/16, CAS: 9002-61-3; 101752/A, Exp: 05/16, CAS 9002-61-3; and 101799/A, Exp: 05/16, CAS: 9002-61-3 Lot Numbers 101751/A, Exp: 05/16, CAS: 9002-61-3; 101752/A, Exp: 05/16, CAS 9002-61-3; and 101799/A, Exp: 05/16, CAS: 9002-61-3. NDC 38779-2673-1, NDC 38779-2673-2, and NDC 38779-2673-6. Class I Labeling: Label Error on Declared Strength; Firm states that erroneous potency information was found on the label. Medisca Inc.
Drugs Lidocaine HCl Injection, USP, 2%, 20 mg per mL, packaged in 5-mL single-dose vials, 10 vials per box, Rx Only, Hospira, Inc., Lake Forest, IL. 60045, NDC 0409-2066-05. Lot 32135DD; Exp 08/15 Class I Presence of Particulate Matter- Confimed customer complaint of particulates embedded in glass container and in contact with product solution. Hospira Inc.
Devices IMMULITE® /IMMULITE® 1000 Systems TIE Total IgE, REF LKIE1, SMN 10380867, IVD --- Siemens Healthcare Diagnostics Products Ltd. Llanberis, Gwynedd, LL55 4EL, UK. For in vitro diagnostic use with the IMMULITE®, IMMULITE® 1000, and IMMULITE® 2000/ IMMULITE® 2000 XPi Systems Analyzers - for the quantitative measurement of Total Immunoglobulin type E (IgE) in serum. Lots 326 through 333 Class II Siemens confirmed an overall average positive bias of 23% against the WHO 2nd IRP 75/502 with the IMMULITE Systems Total IgE assays. Siemens Healthcare Diagnostics
Devices IMMULITE®2000 /IMMULITE® 2000 XPi Systems TIE Total IgE, REF L2KIE2, SMN 10380873, and L2KIE6, SMN 10380872, IVD --- Siemens Healthcare Diagnostics Products Ltd. Llanberis, Gwynedd, LL55 4EL, UK. For in vitro diagnostic use with the IMMULITE®, IMMULITE® 1000, and IMMULITE® 2000/ IMMULITE® 2000 XPi Systems Analyzers - for the quantitative measurement of Total Immunoglobulin type E (IgE) in serum. Lots 260 through 275 Class II Siemens confirmed an overall average positive bias of 23% against the WHO 2nd IRP 75/502 with the IMMULITE Systems Total IgE assays. Siemens Healthcare Diagnostics
Devices IMMULITE/IMMULITE 1000 Systems Androstenedione (Test Code AND), REF LKAO1, SMN 10381158, IVD, 100 test kit size --- Siemens Healthcare Diagnostics Products Ltd. Llanberis, Gwynedd, LL55 4EL, UK For in vitro diagnostic use with the IMMULITE/IMMULITE 1000 and 2000 Systems Analyzers for the quantitative measurement of 4-androstenedione in human serum. Lot Numbers 409 and above Class II Siemens Healthcare Diagnostics confirmed over-recovery of samples with concentrations greater than 5.5 ng/mL with the IMMULITE/IMMULITE 1000 and IMMULITE 2000/IMMULITE 2000 XPi Androstenedione assays (LKAO1, L2KAO2). Siemens has determined that these lots are linear up to a concentration of 5.5 ng/mL, instead of 10 ng/mL as stated in the Instructions for Use (IFU). Quality Control materials at concentrations between 5.5 and 10 ng/mL will detect this issue. Siemens Healthcare Diagnostics
Devices IMMULITE 2000/2000 XPi Systems Androstenedione (Test Code AND), REF L2KAO2, SMN 10381188, IVD, 200 test kit size --- Siemens Healthcare Diagnostics Products Ltd. Llanberis, Gwynedd, LL55 4EL, UK For in vitro diagnostic use with the IMMULITE/IMMULITE 1000 and 2000 Systems Analyzers for the quantitative measurement of 4-androstenedione in human serum. Lot Numbers 314 and above Class II Siemens Healthcare Diagnostics confirmed over-recovery of samples with concentrations greater than 5.5 ng/mL with the IMMULITE/IMMULITE 1000 and IMMULITE 2000/IMMULITE 2000 XPi Androstenedione assays (LKAO1, L2KAO2). Siemens has determined that these lots are linear up to a concentration of 5.5 ng/mL, instead of 10 ng/mL as stated in the Instructions for Use (IFU). Quality Control materials at concentrations between 5.5 and 10 ng/mL will detect this issue. Siemens Healthcare Diagnostics
Drugs Fluoxetine Capsules, USP, 20 mg, 30-count bottles, Rx only, Distributed by: Wal-Mart, Bentonville, AR 72716; Manufactured by: TEVA PHARMACEUTICALS USA, Sellersville, PA 18960; Packaged by: Legacy Pharmaceutical Packaging LLC, Earth City, MO 63045, NDC 68645-130-54, UPC 3 68645 13054 5. Lot numbers: 131328, Exp 08/15; 131634, Exp 09/15; and 131833, Exp 11/15 Class II Chemical Contamination: The recalling firm received notice that their supplier is recalling capsules due to complaints of capsules having an unusual odor. Legacy Pharmaceutical Packaging
Drugs Fluoxetine Capsules USP, 20 mg, packaged in a) 100-count bottles (NDC 50111-648-01), b) 500-count bottles (NDC 50111-648-02), c) 1000-count bottles (NDC 50111-648-03), and d) 2000-count bottles (NDC 50111-648-44), Rx only, Manufactured in Poland By: Pliva Krakow Pharmaceutical Company S.A., Krakow, Poland; Manufactured For: Teva Pharmaceuticals USA, Sellersville, PA 18960. Lot #: a) 6A211150, 6A211151, 6A211152, 6A211153, 6A211154, Exp 11/15; 6A212083, 6A212084, 6A212085, 6A212086, Exp 12/15; b) 6A211143, 6A211145, 6A211146, 6A211147, Exp 11/15; c) 6A209116, 6A209117, 6A209118, 6A209119, 6A209120, Exp 09/15; 6A211139, 6A211140, 6A211141, Exp 11/15; 6A212087, Exp 12/15; d) 6A209124, Exp 09/15; 6A211144, 6A211148, 6A211149, Exp 11/15 Class II Chemical Contamination: Recall due to a customer complaint trend regarding capsule odor. Teva Pharmaceuticals USA
Drugs Fluoxetine Capsules USP, 10 mg, 100-count bottles, Rx only, Manufactured in Poland By: Pliva Krakow Pharmaceutical Company S.A., Krakow, Poland; Manufactured For: Teva Pharmaceuticals USA, Sellersville, PA 18960, NDC 50111-647-01, UPC 3 50111-647-01 5. Lot #: 6A211158, 6A211159, 6A211163, Exp 11/15 Class II Chemical Contamination: Recall due to a customer complaint trend regarding capsule odor. Teva Pharmaceuticals USA
Devices Abbott Acclaim Infusion Pump Designed to deliver parenteral infusions including whole blood or red blood cell components and enteral fluids using a wide variety of standard administration sets and fluid containers. List Number: 12032; Serial Numbers: 12322921, 12323859, 12322780, 12322801, 12322810, 12322812, 12322878, 12322880, 12322887, 12322896, 12322903, 12322904, 12322911, 12322917, 12322936, 12322939, 12323867, 12322916, 12323056, 12321139, 12324767, 12324854, 12324802, 12322873, 12324375, 1231453, 1231610. Class I Hospira has received customer reports of broken door assemblies on the Hospira/Abbott Acclaim Encore infusion pumps. If the door assembly breaks, it may prevent the door from closing properly and unrestricted flow may occur. If the door cannot be closed, the pump cannot be used which can result in a delay in therapy. Hospira Inc.
Devices Hospira Acclaim Encore Infusion Pump Designed to deliver parenteral infusions including whole blood or red blood cell components and enteral fluids using a wide variety of standard administration sets and fluid containers. List Number: 12237; Serial Numbers: 12670196, 12670182  ...
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Class I Hospira has received customer reports of broken door assemblies on the Hospira/Abbott Acclaim Encore infusion pumps. If the door assembly breaks, it may prevent the door from closing properly and unrestricted flow may occur. If the door cannot be closed, the pump cannot be used which can result in a delay in therapy. Hospira Inc.
Drugs Dianeal PD-2 Peritoneal Dialysis Solution with 1.5% Dextrose, 6000 mL Ambu-Flex II container, Rx only, Baxter Healthcare Corporation, Deerfield, IL 60015, Product Code L5B9710, NDC 0941-0411-11 Lot number: C903799, Exp 05/15 Class I Non-Sterility: Complaints of leaks and particulate matter identified as mold in the solution bag and the overpouch. Baxter Healthcare Corp.
Drugs Lupron Depot (Leuprolide Acetate for Depot Suspension) Single Dose Administration Kit with prefilled dual-chamber syringe, 22.5 mg for 3-month administration, Rx only, Manufactured for: AbbVie Inc., North Chicago, IL 60064; by: Takeda Pharmaceutical Company Limited, Osaka, Japan 540-8645; NDC 0074-3346-03, UPC 3 00743 34603 9. Lot #: 1014204, Exp 10/11/15; 1014485, Exp 12/11/16; and 1015007, Exp 12/06/16 Class II Defective Delivery System: Some Lupron Depot Kits may contain a syringe with a potentially defective LuproLoc needle stick protection device. AbbVie Inc
Drugs Lupron Depot (Leuprolide Acetate for Depot Suspension) Single Dose Administration Kit with prefilled dual-chamber syringe, 45 mg for 6-month administration, Rx only, Manufactured for: AbbVie Inc., North Chicago, IL 60064; by: Takeda Pharmaceutical Company Limited, Osaka, Japan 540-8645; NDC 0074-3473-03, UPC 3 00743 47303 2. Lot # 1013976, Exp 09/25/15 Class II Defective Delivery System: Some Lupron Depot Kits may contain a syringe with a potentially defective LuproLoc needle stick protection device. AbbVie Inc
Drugs LUPRON DEPOT-PED (Leuprolide Acetate for Depot Suspension) Single Dose Administration Kit with prefilled dual-chamber syringe, 11.25 mg for 3-month administration, Rx only, Manufactured for: AbbVie Inc., North Chicago, IL 60064; by: Takeda Pharmaceutical Company Limited, Osaka, Japan 540-8645; NDC 0074-3779-03, UPC 3 00743 77903 5. Lot #:1013566, Exp 12/08/16 Class II Defective Delivery System: Some Lupron Depot Kits may contain a syringe with a potentially defective LuproLoc needle stick protection device. AbbVie Inc
Drugs Lupron Depot (leuprolide acetate for depot suspension) Single Dose Administration Kit with prefilled dual-chamber syringe, 11.25 mg for 3-Month administration, Rx only, Manufactured for: AbbVie Inc., North Chicago, IL 60064; by: Takeda Pharmaceutical Company Limited, Osaka, Japan 540-8645; NDC 0074-3663-03, UPC 3 00743 66303 7. Lot #: 1013906, Exp 09/21/16 Class II Defective Delivery System: Some Lupron Depot Kits may contain a syringe with a potentially defective LuproLoc needle stick protection device. AbbVie Inc
Drugs Lupron Depot (Leuprolide Acetate for Depot Suspension) Single Dose Administration Kit with prefilled dual-chamber syringe, 7.5 mg for 1-month administration, Rx only, Manufactured for: AbbVie Inc., North Chicago, IL 60064; by: Takeda Pharmaceutical Company Limited, Osaka, Japan 540-8645; NDC 0074-3642-03, UPC 3 00743 64203 2. Lot #: 1012381, 1012383, Exp 08/22/16 Class II Defective Delivery System: Some Lupron Depot Kits may containin a syringe with a potentially defective LuproLoc needle stick protection device. AbbVie Inc
Devices ExacTrac 6.0 is a patient positioning and monitoring system. Model/catalogue numbers: 20833B EXACTRAC 6.0 IR POSITIONING SOFTWARE 49936 ET SOFTWARE UPDATE 6.0.X TO 6.0.3 49926B ET UPGRADE SOFTWARE 3.X TO 6.0 (IR+XR) 49934A EXACTRAC UPGRADE 5.5 TO 6.0 BASIC 49927B ET UPGRADE SOFTWARE 4.X TO 6.0 (IR+XR) 49928B ET UPGRADE SOFTWARE 5.X TO 6.0 (IR+XR) 49933B ET UPGRADE TRUEBEAM 5.5 TO 6.0 LIMITED 49973B ET DATA PREP / REVIEW SYSTEM 49998B ET 6.0 DATA PREP/REVIEW SYSTEM UPG. KIT 49996B ET UPGRADE SOFTWARE X.X TO 6.0 SW ONLY 49997B ET UPGRADE SOFTWARE 5.5 TO 6.0 LIMITED ExacTrac version v.6.0.3. Class II When using multiple radiation treatment targets within a single plan, the ExacTrac v.6.0.3 might position the patient to an unintended radiation treatment point. As a result, there is a possibility that the radiation treatment dose may be delivered to the unintended target position. Brainlab AG
Food Losurdo IMPORTED GRATED PECORINO ROMANO, NET WT. 80 OZ. (5 LB.) 2.27 Kg, UPC 0 75009 00232 4. Product packaged within black plastic bag, with 5 bags per carton (20 LB) total per carton. Distributor LOSURDO FOODS, INC. 20 Owens Roads Hackensack, NJ 07601. Lot number: 021914 Class II Losurdo Foods has recalled one lot of Grated Cheese Pecorino Romano due to Listeria monocytogenes contamination. Losurdo Foods Inc
Biologics Invitrogen by Life Technologies, AllSet+⢠Gold SSP HLA ABC Low Res Kit, REF 54340D. Lot 038 1249868 Class II HLA typing assay, associated with false typing assignments, was distributed. Life Technologies Corporation
Drugs Venlafaxine Hydrochloride Extended-Release Tablets, 150 mg, packaged in a) 30-count bottles (NDC 41616-758-83, UPC 3 41616 75883 2); and b) 90-count bottles (NDC 41616-758-81, UPC 3 41616 75881 8), Rx only, Distributed by: Caraco Pharmaceutical Laboratories, Ltd., 1150 Elijah McCoy Drive, Detroit, MI 48202; Manufactured at: Sun Pharmaceutical Ind. Ltd., Halol-Baroda Highway, Halol-389 350, Gujarat, India. Lot #: a) JKL3354A, Exp 04/14; JKL5444A, Exp 08/14; JKL5457B, JKL5445A, Exp 09/14; JKL5840A, Exp 10/14; JKL6588A, Exp 11/14; b) JKL3354B, Exp 04/14; JKL5444B, Exp 08/14; JKL5457C, JKL5445B, Exp 09/14; JKL5840B, Exp 10/14. Class II Failed Dissolution Specifications: Stability results found the product did not meet the drug release dissolution specifications. Caraco Pharmaceutical Laboratories, Ltd.
Drugs Venlafaxine Hydrochloride Extended-Release Tablets, 37.5 mg, packaged in a) 30-count bottles (NDC 41616-760-83, UPC 3 41616 76083 5); and b) 90-count bottles (NDC 41616-760-81, UPC 3 41616 76081 1), Rx only, Distributed by: Caraco Pharmaceutical Laboratories, Ltd., 1150 Elijah McCoy Drive, Detroit, MI 48202; Manufactured at: Sun Pharmaceutical Ind. Ltd., Halol-Baroda Highway, Halol-389 350, Gujarat, India. Lot #: a) JKL4344A, Exp 07/14; JKL5460A, Exp 10/14; JKL5458A, Exp 11/14; b) JKL4344B, Exp 07/14; JKL5460B, Exp 10/14; JKL5458B, Exp 11/14. Class II Failed Dissolution Specifications: Stability results found the product did not meet the drug release dissolution specifications. Caraco Pharmaceutical Laboratories, Ltd.
Devices Fisherbrand Sterile Swabs, Calcium Alginate Fiber Tipped Aluminum Applicator Swab, .025 and .035 in Diameter, all lots, 100 per pack Fisherbrand Sterile Swabs, Calcium Alginate Fiber Tipped Plastic Applicator Swab, all lots, 100 per pack Fisherbrand Sterile Swabs, Calcium Alginate Fiber Tipped Wood Applicator Swab, all lots, 100 and 200 per pack culture collection and industrial surfaces all lots of article nos. 14-959-77, 14-959-78, 14-959-79, 14-959-81, 14-959-82, lots 60151, 61513, 61933, 62768, 63055, 60752, 61324, 62195, 63224, 60752, 62195, 61866, 62546, 8710, with expiration dates August 2014 through October 2015 Class II A customer reported the presence of an organism in a lot of Calcium Alginate Fiber Tipped Wood Applicator Swab. Fisher Scientific Co
Biologics Blood and Blood Products for Reprocessing W0410111987753 Class II Blood product, collected from a donor who was at risk for variant Creutzfeldt-Jakob Disease (vCJD), was distributed. Blood Systems Inc
Devices GemStar Docking Station, used with GemStar infusion pump, in combination with other GemStar accessories such as the GemStar Lock Box and patient bolus cord. The docking station is also used for hosting the GemStar pump for general infusions. List Numbers: 13075-XX-XX *** US DOCKING STATIONS *** List Numbers: 13075-04-01, 13075-04-03, 13075-04-05, 13075-04-07, 13075-04-09. *** FOREIGN DOCKING STATIONS *** List Numbers: 13075-24-01, 13075-24-03, 13075-24-05, 13075-24-07, 13075-92-09 Class I There are two situations that may occur when using the GemStar Docking Station, List Number 13075-XX-XX, in conjunction with the GemStar infusion pump: 1) when the Docking Station is used in conjunction with a GemStar Phase 3 pump (List 13000-XX, 13100-XX, or 13150-XX) the potential exists for the GemStar Phase 3 pump to fail to power up while connected to the Docking Station, and 2) when either a GemStar Phase 3 (List 13000-XX, 13100-XX, or 13150-XX)or GemStar Phase 4 pump (List 13086-XX, 13087-XX, or 13088-XX) is used in conjunction with both a Docking Station and an External Battery Pack accessory (List 13073-XX) there exists a possibility that the GemStar pump will display error code 11/003 and give an audible alarm indicating excessive input voltage from the external sources. If the GemStar pump detects what is perceived to be more than 3.6 Volts measured on the external voltage input, the pump will stop the infusion and alarm both with an audible sound as well as a visual alarm. Hospira Inc.
Drugs GLYBURIDE and METFORMIN HYDROCHLORIDE Tablets USP, 5mg/500mg, 500 count bottle, Manufactured In INDIA By: EMCURE PHARMACEUTICALS LTD harmaceuticals Ltd., Hinjwadi, Pune, India, Manufactured For: TEVA PHARMACEUTICALS USA, Sellersville, PA 18960, NDC: 0093-5712-05 TE36018, Exp. 06/15 Class II This recall was initiated because laboratory testing was not followed in accordance with GMP requirements. Teva Pharmaceuticals USA
Drugs INDOMETHACIN Capsules USP, 25 mg 100 count bottle, Rx only , Manufactured In INDIA By: EMCURE PHARMACEUTICALS LTD harmaceuticals Ltd., Hinjwadi, Pune, India, Manufactured For: TEVA PHARMACEUTICALS USA, Sellersville, PA 18960, NDC 0093-4029-01 TE32134, Exp. 02/15 Class II This recall was initiated because laboratory testing was not followed in accordance with GMP requirements. Teva Pharmaceuticals USA
Drugs INDOMETHACIN Capsules USP, 50 mg, a) 100 count bottle, (NDC 0093-4030-01), b) 500 count bottle, (NDC 0093-4030-05), Manufactured In INDIA By: EMCURE PHARMACEUTICALS LTD harmaceuticals Ltd., Hinjwadi, Pune, India, Manufactured For: TEVA PHARMACEUTICALS USA, Sellersville, PA 18960 TE38139, Exp. 08/16, TE39022, Exp. 09/16, Class II This recall was initiated because laboratory testing was not followed in accordance with GMP requirements. Teva Pharmaceuticals USA
Drugs METHYLDOPA Tablets USP, 500 mg, 100 count bottle, Rx only, Manufactured In INDIA By: EMCURE PHARMACEUTICALS LTD harmaceuticals Ltd., Hinjwadi, Pune, India, Manufactured For: TEVA PHARMACEUTICALS USA, Sellersville, PA 18960, NDC 0093-2932-01 TE36053A,TE36063A, Exp. 06/16 Class II This recall was initiated because laboratory testing was not followed in accordance with GMP requirements. Teva Pharmaceuticals USA
Drugs Phosphatidylcholine Solution for Injection, 50 mg/ mL, 50 mL Vial, Rx Only, Not for Resale. John Hollis Pharmacy, 110 20th Avenue N, Nashville, TN 37203. Lot #: 41652, Expiry: 8/2/14; Lot #: 41668, Expiry: 7/13/14 Class II Labeling: Incorrect Expiration Date; Expiration date is earlier than listed on vial. John W Hollis Inc
Drugs Papaverine 60 mg, Phentolamine 4 mg, and Atropine 0.3 mg Solution, 10 mL Vial, Rx Only. Not for Resale. John Hollis Pharmacy, 110 20th Avenue N, Nashville, TN 37203. Lot #: 1905, Expiry: 4/30/14 Class III Labeling: Incorrect Expiration Date; Expiration date is earlier than listed on vial. John W Hollis Inc
Drugs Polidocanol 1% Solution, 50 mL Vial, Rx Only, Not for Resale. John Hollis Pharmacy, 110 20th Avenue N, Nashville, TN 37203. Lot #: 565:27, Expiry: 5/31/14 Class III Labeling: Incorrect Expiration Date; Expiration date is earlier than listed on vial. John W Hollis Inc
Drugs Polidocanol 3% Solution, 50 mL Vial, Rx Only, Not for Resale. John Hollis Pharmacy, 110 20th Avenue N, Nashville, TN 37203. Lot #: 641:07, Expiry: 8/11/14 Class II Presence of Particulate Matter John W Hollis Inc
Biologics Cornea 12292013017OD; 12292013017OS Class II Human Corneas, recovered from donors whose donor eligibility was not determined by using appropriate FDA-licensed, approved, or cleared donor screening tests, in accordance with the manufacturer's instructions, to adequately and appropriately reduce the risk of transmission of relevant communicable disease agents or diseases, were distributed. Mid-America Transplant Services
Biologics Micro SSP" Allele Specific HLA Class I DNA Typing Tray-C*02, Catalog Identification: SSPR1-C02. BK960062 Catalog Identification: SSPR1-C02. Micro SSP" Allele Specific HLA Class I DNA Typing Tray  C*02  Catalog Identification: SSPR1-C02 Article Number: SSP_DNAT_PI Rev 18 Lot number: 002, batches 001-006 (Batch 002 not distributed). Class II HLA typing assay, associated with false typing assignments, was distributed. One Lambda Inc
Food Holiday Foods, Cheddar Cheese Puffs, 4800308, UPC 70220748003081, 100 PCS, Not Fully Cooked - Cook Before Eating, Keep Frozen, For Institutional Use Only, Prepared by Holiday Food Inc, Hollywood, Florida 33020. 4800308 Class II Schwans Food Company is recalling Cheddar Cheese Puffs and Gourmet Cold Canapes Assortment manufactured by Holiday Foods, Inc that were prepared with ingredients which are being recalled by Parker Farm Inc. because of the potential of Listeria monocytogenes contamination. Schwan's Global Supply Chain, Inc. (This correction has already been made)
Food Holiday Foods Gourmet Cold Canapes Assortment, 4800361, UPC 70220748003616, 100 OCS. Keep Frozen, For Institutional Use Only, Defrost in Refrigerator for Approximately 3 hours Before Serving, Consume Immediately. Prepared by Holiday Foods Inc, Hollywood, Florida 33020. 4800361 Class I Schwans Food Company is recalling Cheddar Cheese Puffs and Gourmet Cold Canapes Assortment manufactured by Holiday Foods, Inc that were prepared with ingredients which are being recalled by Parker Farm Inc. because of the potential of Listeria monocytogenes contamination. Schwan's Global Supply Chain, Inc. (This correction has already been made)
Devices VITROS Chemistry Products Specialty Diluent, REF 855 9825, 6 x 3 mL, IVD --- Ortho-Clinical Diagnostics, Inc. Rochester, NY Lot F3168 (exp. 30 Sep 2014) Class II Ortho Clinical Diagnostics (OCD) confirmed the potential for lower than expected C-Reactive Protein (CRP) results only to be generated when using VITROS Chemistry Products Specialty Diluent (Lot F3168) or VITROS Chemistry Products FS Diluent Pack 3 (Lot 01-3266). The VITROS Instructions for Use states that if the if a C-reactive protein concentration exceeds the systems measuring (reportable or dynamic) range, dilute the sample with VITROS Specialty Diluent or a patient sample containing a low concentration of CRP. An initial threefold dilution is recommended. Internal testing determined that results using VITROS CRP Slides have the potential for approximately 51% bias using a 3x dilution factor. Ortho-Clinical Diagnostics
Devices VITROS Chemistry Products FS Diluent Pack 3, REF 680 1754, 3 x 45 mL, (D1)/15 mL (D2), IVD --- Ortho-Clinical Diagnostics, Inc. Rochester, NY, 14626 Lot 01-3266 (exp. 23-SEPTEMBER-2014) Class II Ortho Clinical Diagnostics (OCD) confirmed the potential for lower than expected C-Reactive Protein (CRP) results only to be generated when using VITROS Chemistry Products Specialty Diluent (Lot F3168) or VITROS Chemistry Products FS Diluent Pack 3 (Lot 01-3266). The VITROS Instructions for Use states that if the if a C-reactive protein concentration exceeds the systems measuring (reportable or dynamic) range, dilute the sample with VITROS Specialty Diluent or a patient sample containing a low concentration of CRP. An initial threefold dilution is recommended. Internal testing determined that results using VITROS CRP Slides have the potential for approximately 51% bias using a 3x dilution factor. Ortho-Clinical Diagnostics
Devices The Osteo-Clage System consists of stainless steel cable/sleeves and compression plates. . 2.0 mm x 850mm SS Cable/Sleeve; Part Number 01-0020-S 2.0 mm SS Sleeve Only; Part Number 01-0022-S 8, 7 hole, SS compression plate; Part Number 02-2007-S 10, 9 hole, SS compression plate; Part Number 02-2009-S Product Usage: The Osteo-Clage Stainless Steel Bone Plate is an implantable straight, rigid stainless steel plate. It is used in conjunction with 4.5mm Cortical bone screws to provide compression across bone fractures. The Osteo-Clage Cerclage Wire Crimp sleeve is used in conjunction with the bone plate in cerclage fixation procedures. 2.0mm x 80mm SS cable/sleeve: Lot # 222078, 232175, 245032, 254368, 261903, 270659, 284155, 297281. 2.0mm SS sleeve only: Lot # 247553, 267469, 280871, 313261. 8, 7 hole SS compression plate: Lot # 300381. 10, 9 hole SS compression plate: Lot # 299641. Class II Acumed is voluntarily recalling specific lot numbers of Osteo-Clage Stainless Steel Bone Plates and Tension Band Pins due to the manufacturing of these devices with a grade of stainless steel that is not within specifications. Acumed LLC
Devices The Acumed Tension Band Pin is a fixation pin which is .0625" in diameter and is available in lengths between 35mm and 90mm. It is to be used in conjunction with commonly used orthopedic wire. 50.0 mm Tension Band Pin; Part Number 30-0097 70.0 mm Tension Band Pin; Part Number 30-0098 90.0 mm Tension Band Pin; Part Number 30-0099 50.0 mm Tension Band Kit; Part Number TB-1550K-S 70.0 mm Tension Band Kit; Part Number TB-1570K-S 90.0 mm Tension Band Kit; Part Number TB-1590K-S Product Usage: Acumed Tension Band Pin is intended to be used with orthopedic wire to address malleolar, patella, and olecranon fractures in tension band wiring procedures. This device is not intended for usage in the spine. 50.0 mm Tension Band Pin: Lot 243639 70.0 mm Tension Band Pin: Lots 241127, 242707, 243325, 243948. 90.0 mm Tension Band Pin: Lots 241128. 242708, 243327, 243949. 50.0 mm Tension Band Kit: Lots 216769, 217002, 217941, 219145, 219402, 222732, 223007, 224312, 229889, 232575, 235490, 237772, 244800, 246204, 247056. 70.0 mm Tension Band Kit: Lots  ...
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Class II Certain lots of Acumed Tension Band Pins are being recalled because the implantable product was manufactured with a grade of stainless steel that is not within specifications. Acumed LLC
Devices Alfa Wassermann Diagnostic Technologies, LLC. ACE ALT Reagent. Product Usage: For quantitative determination of ALT in serum and lithium heparin plasma using ACE®, ACE Alera® and ACE Axcel Clinical Chemistry Systems. This test is intended for use in clinical laboratories and physician office labs. ACE® ALT Reagent (Product reorder number SA1046 Lot F3604) Class II Extremely low absorbance readings. Alfa Wassermann, Inc.
Devices Alfa Wassermann Diagnostic Technologies, LLC. ACE AST Reagent. Product Usage: For quantitative determination of AST in serum and lithium heparin plasma using ACE®, ACE Alera® and ACE Axcel Clinical Chemistry Systems. This test is intended for use in clinical laboratories and physician office laboratories. ACE® AST Reagent Product reorder numbers SA1047 (Lot F3609) and RX1047 (Lot F3610) Class II Extremely low absorbance readings. Alfa Wassermann, Inc.
Veterinary Triple Cleaned Corn, 50 LBS NET, Packaged by: Southern Seed and Feed, Macon, MS None. Recall includes two shipments delivered 03/04/2014 and 03/07/2014 Class II Sample of product found Fumonisin above the recommended limit of 5 PPM. SOUTHERN SEED & FEED
Devices Nuclear gamma cameras (ADAC Vertex Plus, ADAC Solus, ADAC Vertex V60 & ADAC Vertex Classic) Philips Medical System, Cleveland, OH 44143. Used to produce images depicting the anatomical distribution of single photon and positron emitting radioisotopes with the human body for interpretation by medical personnel. ADAC Vertex Plus & ADAC Solus System Code: 88297, Serial #'s: 11, 1006, 1008, 1027, 1092, 1097, 2035, 2038, 2047, 3059, 3060, 3064, 4007, 4078, 6052, 6261, 8002, 10252, 10630, 11090, 85247, 513519, 513520, 940384, 9205345, 9408136, 9503084, 9506016, 9511123, 9512009, 9512018, 9601012, 9601015, 9601016, 9601024, 9601036, 9602161, 9602254, 9603336,  ...
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Class II Slippage of the radius drive belt in the relative 180 degree orientation of the superior positioned detector head will allow the detector head to drift down and potentially come in direct contact with the patient. Philips Medical Systems (Cleveland) Inc
Devices Integra CUSA Excel Disposable Wrench. Catalog Number C5601. The CUSA Excel+ Sterile 23 kHz Torque Wrench is an accessory used with the CUSA Excel+ System ultrasonic surgical instrument. The torque wrench is used to properly secure the CUSA tip to the CUSA handpiece in the sterile field. Product/Catalog Number C5601; Lot Numbers 1132424, 1132883, 1132884, 1133453, 1133454, 1133455, 1134067, 1134675, 1134873 and 1135014 Class II Some 23 kHz Torque Wrenches were incorrectly assembled and contained a 36 kHz Hex Wrench Insert instead of the 23 kHz Hex Wrench Insert. Integra LifeSciences Corp.
Food RISING MOON ORGANICS BASIL ASIAGO PINE NUT PESTO RAVIOLI; 8 OZ PACKAGE (227g) Keep Frozen USDA Organic: Distributed by Rising Moon Organics 313 Iron Horse Way Providence, RI 02908 LOT # 011615 UPC # 7 85030 55555 2 Class III Basil, Asiago & Pine Nut Pesto Ravioli is labeled with the ingredient statement for Itsy Bitsy ravioli and therefore does not include Pine Nuts in the ingredient or allergen statement. Carmel Food Group, Inc.
Drugs Potassium Chloride for Inj. Concentrate, USP, 40 mEq (2 mEq/mL), 20 mL Single-dose Fliptop Vial, For IV use, Rx only, Hospira, Inc., Lake Forest, IL 60045 USA Lot 22-127-DK Class II Presence of Particulate; red and black particulate within the solution and embedded within the plastic vial identified as iron oxide Hospira Inc.
Biologics Red Blood Cells Leukocytes Reduced W116113010801 Class II Blood products, collected from a donor who was at risk for variant Creutzfeldt-Jakob Disease (vCJD), were distributed. Avera McKennan Hospital & University Health Center
Biologics Plasma W116113010801 Class II Blood products, collected from a donor who was at risk for variant Creutzfeldt-Jakob Disease (vCJD), were distributed. Avera McKennan Hospital & University Health Center
Biologics Red Blood Cells 2525365 Class II Blood products, collected from a donor for whom donor suitability was not adequately determined, were distributed. OneBlood, Inc.
Biologics Cryoprecipitated AHF 2525365 Class II Blood products, collected from a donor for whom donor suitability was not adequately determined, were distributed. OneBlood, Inc.
Biologics Red Blood Cells (Apheresis) Leukocytes Reduced W1428140047537; W142814006581K Class II Blood products, with unacceptable cell recovery rates, were distributed. Blood Systems, Inc
Devices Anti EpCam PE - Analyte Specific Reagent. Anti-EpCAM is directed against human epithelial adhesion molecule that has been identified as a 40 -kilodalton (kd) protein in Western Blotting. Catalog number 347211; Lot number 3295974 - expiry date 2015-09-30; Lot number 3259822 - expiry date 2015-09-30. Class II Two lots of Anti EpCAM PE-Analyte Specific Reagent are mislabeled - the actual antibody present in the vial is CD9 PE. BD Biosciences, Systems & Reagents
Devices PolypVac 3.5mm Microdebrider; Catalog Number FG-000016; contents: 1 Microdebrider, 1 Stylet, 1 filter. Sterile. Used for the excision of polyps in the nasal passageways and in sinuses for which access has been previously established. Lot Number: LFG-111813-1; Expiry date: June 2014; LFG020614-01, Expiry date: September 2014. Class III The reciprocation mechanism in the PolypVac Microdebrider may turn off prematurely due to a component failure in the device handle. Laurimed LLC
Biologics Blood and Blood Products for Reprocessing W036811027628; W036810197134 Class III Blood products, collected from a donor in which donor suitability was not adequately determined, were distributed. OneBlood, Inc.
Biologics Red Blood Cells W036810197134; W036811027628 Class II Blood products, collected from a donor in which donor suitability was not adequately determined, were distributed. OneBlood, Inc.
Food Pastene MAFALDINE 5, 16 oz cellophane bag Imported from Italy. Imported by the Pastene Company, Canton, MA Item Number: 7062 UPC: 066086070627 All Lots in Commerce Class II Semolina pasta fails to declare the allergen"wheat" The Pastene Companies Ltd.
Food Pastene GEMELLI 104, 16 oz cellophane bag Imported from Italy. Imported by the Pastene Company, Canton, MA Item Number: 7063 UPC: 066086070634 All Lots in Commerce Class II Semolina pasta fails to declare the allergen"wheat" The Pastene Companies Ltd.
Food Pastene REGINE 10, 16 oz cellophane bag. Imported from Italy. Imported by the Pastene Company, Canton, MA Item Number: 7064 UPC: 066086070641 All Lots in Commerce Class II Semolina pasta fails to declare the allergen"wheat" The Pastene Companies Ltd.
Food Pastene FARFALLINE 78, 16 oz cellophane bag. Imported from Italy. Imported by the Pastene Company, Canton, MA Item Number: 7067 UPC: 066086070672 All Lots in Commerce Class II Semolina pasta fails to declare the allergen"wheat" The Pastene Companies Ltd.
Food Pastene ITAL TAGLIATELLE VERDI #80, 16 oz cellophane bag. Imported from Italy. Imported by the Pastene Company, Canton, MA Item Number:7070 UPC: 066086070702 All Lots in Commerce Class II Semolina pasta fails to declare the allergen"wheat" The Pastene Companies Ltd.
Food Pastene ITAL CAPELLI D'ANGELO #83, 16 oz cellophane bag. Imported from Italy. Imported by the Pastene Company, Canton, MA Item Number:7074 UPC: 066086070740 All Lots in Commerce Class II Semolina pasta fails to declare the allergen"wheat" The Pastene Companies Ltd.
Food Pastene ITALIAN SPAGHETTI #15, 16 oz cellophane bag. Imported from Italy. Imported by the Pastene Company, Canton, MA Item Number:7075 UPC: 066086070757 All Lots in Commerce Class II Semolina pasta fails to declare the allergen"wheat" The Pastene Companies Ltd.
Food Pastene ITALIAN LINGUINE #6, 16 oz cellophane bag. Imported from Italy. Imported by the Pastene Company, Canton, MA Item Number:7077 UPC: 066086070771 All Lots in Commerce Class II Semolina pasta fails to declare the allergen"wheat" The Pastene Companies Ltd.
Food Pastene ITALIAN ZITI RIGATI #20, 16 oz cellophane bag. Imported from Italy. Imported by the Pastene Company, Canton, MA Item Number:7079 UPC:066086070795 All Lots in Commerce Class II Semolina pasta fails to declare the allergen"wheat" The Pastene Companies Ltd.
Food Pastene ITALIAN FUSILLI #28, 16 oz cellophane bag. Imported from Italy. Imported by the Pastene Company, Canton, MA Item Number:7081 UPC: 066086070818 All Lots in Commerce Class II Semolina pasta fails to declare the allergen"wheat" The Pastene Companies Ltd.
Food Pastene ITALIAN CAPELLINI #17, 16 oz cellophane bag. Imported from Italy. Imported by the Pastene Company, Canton, MA Item Number:7082 UPC: 066086070825 All Lots in Commerce Class II Semolina pasta fails to declare the allergen"wheat" The Pastene Companies Ltd.
Food Pastene ITALIAN RIGATONI #31 , 16 oz cellophane bag. Imported from Italy. Imported by the Pastene Company, Canton, MA Item Number:7083 UPC: 066086070832 All Lots in Commerce Class II Semolina pasta fails to declare the allergen"wheat" The Pastene Companies Ltd.
Food Pastene ITALIAN SHELLS #25 , 16 oz cellophane bag. Imported from Italy. Imported by the Pastene Company, Canton, MA Item Number:7084 UPC: 066086070849 All Lots in Commerce Class II Semolina pasta fails to declare the allergen"wheat" The Pastene Companies Ltd.
Food Pastene ITALIAN DITALI #45 , 16 oz cellophane bag. Imported from Italy. Imported by the Pastene Company, Canton, MA Item Number:7085 UPC: 066086070856 All Lots in Commerce Class II Semolina pasta fails to declare the allergen"wheat" The Pastene Companies Ltd.
Food Pastene ITALIAN STELLINE #59 , 16 oz cellophane bag. Imported from Italy. Imported by the Pastene Company, Canton, MA Item Number:7086 UPC: 066086070863 All Lots in Commerce Class II Semolina pasta fails to declare the allergen"wheat" The Pastene Companies Ltd.
Food Pastene ITALIAN TRIVELLA #69 , 16 oz cellophane bag. Imported from Italy. Imported by the Pastene Company, Canton, MA Item Number:7087 UPC: 066086070870 All Lots in Commerce Class II Semolina pasta fails to declare the allergen"wheat" The Pastene Companies Ltd.
Food Pastene ITAL NIDI #81 ,16 oz cellophane bag. Imported from Italy. Imported by the Pastene Company, Canton, MA Item Number:7090 UPC: 066086070900 All Lots in Commerce Class II Semolina pasta fails to declare the allergen"wheat" The Pastene Companies Ltd.
Food Pastene ITALIAN FARFALLE #66 ,16 oz cellophane bag. Imported from Italy. Imported by the Pastene Company, Canton, MA Item Number:7091 UPC: 066086070917 All Lots in Commerce Class II Semolina pasta fails to declare the allergen"wheat" The Pastene Companies Ltd.
Food Pastene ITALIAN PAPPARDELLE ,16 oz cellophane bag. Imported from Italy. Imported by the Pastene Company, Canton, MA Item Number:7092 UPC: 066086070924 All Lots in Commerce Class II Semolina pasta fails to declare the allergen"wheat" The Pastene Companies Ltd.
Food Pastene ITALIAN BUCATINI,16 oz cellophane bag. Imported from Italy. Imported by the Pastene Company, Canton, MA Item Number:7095 UPC: 066086070955 All Lots in Commerce Class II Semolina pasta fails to declare the allergen"wheat" The Pastene Companies Ltd.
Food Pastene ITALIAN ORECCHIETTE ,16 oz cellophane bag. Imported from Italy. Imported by the Pastene Company, Canton, MA Item Number:7097 UPC: 066086070979 All Lots in Commerce Class II Semolina pasta fails to declare the allergen"wheat" The Pastene Companies Ltd.
Food Pastene ITAL LONG FUSILLI ,16 oz cellophane bag. Imported from Italy. Imported by the Pastene Company, Canton, MA Item Number:7098 UPC: 066086070986 All Lots in Commerce Class II Semolina pasta fails to declare the allergen"wheat" The Pastene Companies Ltd.
Food Pastene ITAL TRICOLOR FARFALLE ,16 oz cellophane bag. Imported from Italy. Imported by the Pastene Company, Canton, MA Item Number:7088 UPC: 066086070887 All Lots in Commerce Class II Semolina pasta fails to declare the allergen "wheat" The Pastene Companies Ltd.
Food Pastene ITAL SPIRAL TRI COLOR,16 oz cellophane bag. Imported from Italy. Imported by the Pastene Company, Canton, MA Item Number:7093 UPC: 066086070931 All Lots in Commerce Class II Semolina pasta fails to declare the allergen "wheat" The Pastene Companies Ltd.
Drugs Cetirizine Hydrochloride Chewable Tablets, 5 mg, 30 count bottle, OTC Manufactured by Sun Pharma, Gujarat, India, NDC 47335-343-83 JKM2067A Exp. 07/14, JKM2068A Exp.10/14, JKM2069A Exp. 01/15, JKM6399A Exp. 04/15 Class III Failed Impurities/Degradation Specifications: Stability testing found the product may not meet the drug release specification through expiry. Caraco Pharmaceutical Laboratories, Ltd.
Drugs Children's Cetirizine Hydrochloride Chewable Tablets, 10 mg, 30 count bottle, OTC, Manufactured by Sun Pharma, Gujarat, India, Distributed Chain Drug Consortium, Boca Raton, FL, NDC 47335-344-83 JKM2070A Exp. 07/14, JKM2071A Exp.10/14, JKM2072A Exp. 01/15, JKM2072B Exp. 01/15, JKM6400A Exp. 04/15 Class III Failed Impurities/Degradation Specifications: Stability testing found the product may not meet the drug release specification through expiry. Caraco Pharmaceutical Laboratories, Ltd.
Devices CAPIO, Monodeck, Violet Monofilament Polydioxanone Suture, 1 x 48 inches (122cm) Absorbable Surgical Suture, Rx Only, Teleflex Medical. Product Code: 833-137. Product Code: 833-137, Lot numbers: 02A0901938, 02B0901537, 02H1001025, 02H1001026, 02H1001027, 02C1102979, 02C1102983, 02D1300294, 02D1301164, 02C1302078, 02D1302468. Class II The product did not meet minimum and/or average minimum Teleflex resorption strength requirements. Teleflex Medical
Devices Dekna-lok, 1 x 17.78 cm, Violet Braided Polyglycolic Acid Coated Suture, Synthetic Absorbable Surgical Suture USP, Rx Only, Sterile. Teleflex Product Code: 200101-01. Product Code: 200101-01, Lot # 02F0801290 and Product Code: BP1000V2L, Lot numbers: 02C1003535 & 02F1000711. Class II The product did not meet minimum and/or average minimum Teleflex resorption strength requirements. Teleflex Medical
Drugs 0.9% Sodium Chloride Irrigation, USP, 1000 mL,Not for Injection, Manufactured by Baxter Healthcare Corporation, Deerfield, IL 60015, USA, NDC 0338-0048-04. Lot # Gl09272; Exp 09/16 Class II Presence of Particulate Matter: Nylon fibers found in a bottle of 0.9% sodium chloride for irrigation. Baxter Healthcare Corp.
Drugs Risperidone Oral Solution, 1 mg/mL, 30 mL bottle, Rx only, Manufactured by Apotex Inc., Toronto, Ontario, Canada M9L 1T9, Manufactured for Apotex Corp., Weston, FL 33326, NDC 60505-0380-1. Lot #: KD4855, Exp 06/14 Class III Failed Impurities/Degradation Specifications: Out of Specification for an impurity at the 18 month stability time point. Apotex Inc.
Food Fish Oil Softgel Capsules in white High Density Poly-Ethylene bottles labeled in part: "Major [brand] Fish Oil Cholesterol Free 1000 MG *** 100 Softgels *** Distributed by Major Pharmaceuticals ***Livonia, MI 48150 USA ***". Lot #107945 Class II Conjugated Linoleic Acid (CLA) softgel capsules and Fish Oil capsules were found mixed together in a retail bottle labeled as1000 mg Fish Oil soft gel capsules. Nutri-Force Nutrition, Inc.
Drugs Maximum Strength/Non-Drowsy Tussin DM Adult Maximum Strength, Cough Cold, Dextromethorphan HBr, USP, 10 mg (Cough Suppressant) , Guaifenesin, USP, 200 mg (Expectorant), 4, 8 fl oz bottles , OTC only, labeled as A) CareOne 8 fl oz bottle, Distributed by American Sales Company, Lancaster, NY 14086, UPC 341520339677, B) Our Family 4 fl oz bottle, Distributed by Nash Finch Company, NFC Brands, MPLS, MN 55435, UPC 070253579523, C) Premier Value 4, 8 fl oz bottle, Distributed by Chain Drug Consortium, LLC., Boca Raton, FL 33431, 4 fl oz UPC 840986024719; 8 fl oz UPC 840986024726, NDC 68016-177-XX, D) Rexall 4 fl oz bottle, Packaged for Dolencorp, LLC, Goodlettsville, TN 37072, UPC 715256714044, E) Safeway 4 fl oz, Distributed by Safeway INC, Pleasanton, CA 94566-0009, UPC 321130763581; F) Select Brand 4, 8 fl oz, Distributed by Select Brand Distributers, Pine Bluff, AR 71603, 4 fl oz UPC 015127024303; 8 fl oz UPC 015127024310. Lot #: 73762, 80030, 82053, 83032, 73768, 76414, 78222, 78441, 140423, 140494, 142396,145460,145959, 73831, 73832, 78440, 79819, 82606, 80969, 140530, 142413, 145461, 74163; Exp 06/14 Lot #:148820, 149396, 149995, 150208, 150422, 150599, 151023, 151071,151337, 148931,151072. ; Exp 08/15 Class III Presence of Precipitate; white substance confirmed as Guaifenesin, an active ingredient was observed in some bottles. Aaron Industries Inc
Drugs Sevoflurane, USP (Inhalation Anesthetic), Rx Only, 250 mL Amber Bottle. Manufactured By: Piramal Critical Care, 3950 Schelden Circle, Bethlehem, PA 18017. NDC: 66794-015-25. Lot #: S2611I28 (exp 9/16), S2511I14 (exp 9/16), S2531I16 (exp 9/16), S2721J21 (exp 10/16), S2871K03 (exp 11/16), S2881K03 (exp 11/16), and S2931K07 (exp 11/16). Class II Failed pH Specifications: product was too acidic. Piramal Critical Care, Inc.
Devices GE Healthcare, CardiacVX [CardiacVX (1.1.0 Ext. d) and CardiacVX Flow (1.1.0 Ext. d) analysis software running on Advantage Workstation]. Model #'s 5434389-2 and 5434384-2. The GE Cardiac VX for MRI is an analytical software tool, which provides reproducible tools for the review and reporting of medical images. FMI# 60857 & Descr: CARDIAC VX Mfg Lot or Serial # System ID 00000D13194001 0000AP12171002 00000L0240862D 604682AWW4 00000287171GE3 00000322015GE9 00000287170GE5 506648AW1 00000328735GE6 00000281269GE1 604875AW1 00000LA714FC0A 562225MR2A 00000287169GE7 PASSMR1AW 00000Y13168001 M1102608 00000M13099001 RE1046AW01 00000P13074002 M4189445 00000S13081001 M4189445 00000L02687172 M2322216 00000L0240825E M2322233 00000L3A2D12BA M2322241 0000AN12171001 M155485707 0000AP12178001 M40345204 00000R13178002 M178710405 00000T13185001 M2426003 00000L13184001 M1248303 00000H13032001 A4463335 00000N13172001 M4482629 00000L13197001 00000N13030001 I9237520 00000M12341002 0000AN12171002 M2844538 0000AM12178005 C2195283 00000X12340001 C2195282 0000AM12178001 M2322247 00000M12341001 M2322247 0000AP12290001 X59655524 00000B12299001 X59655525 00000N13112001 M2148251 0000AA12213001 M4181459 0000AR12310001 M4166643 0000AD12321001 M9481854 00000R12325001 M9481855 00000M13135001 00000L020E0B14 A54013104 00000L3A3E5D1C A5624137 00000L3A5D9820 A5624137 00000H13071001 A5164528 00000LA71385A1 A5164527 0000AM12178002 A5624134 0000AA13107002 RL6035 00000P13010001 PZ0383 00000T13158001 PM0032 00000L3AB045C6 PM0278 00000X13200001 0000AM12178004 RL6025 00000V13009001 RL6059 0000AM12178003 RL6043 00000G12362001 JW0128 0000AM12178006 PMW087 0000ZA12135001 RL6009 0000AR12310002 RL6123 00000E12356001 PY0207 00000U13057001 RL6092 00000L13014001 RL6111 00000M13024001 RL6071 00000P13004001 RLW118 00000G13038001 RL6088 00000P13074001 RL6096 00000Q13092001 00000H13032002 0850270409AW1 0000AN12171003 0850270411AW1 0000AP12178002 KW1112AW03 0000AN12312001 0920499069 00000328736GE4 00000H13032003 PL1735AW08 00000L3A2CA72F PL1735AW01 00000LA71BD437 600042AW11 00000L3A2D1359 PL1751AW02 00000R12328001 PL2902AW01 00000Q13102001 PL1050AW02 00000N13022001 00000T13043001 SA1051AW03 0000AE13108001 0000AA13113001 00000R13178001 00000Z13190001 0000AF13098001 SA1255AW02 00000R13029001 00000L8B19A930 NP739729 00000V13009002 NP413434 0000AN12292001 NEV13614 0000AA13107001 O009AW11 00000A13192001 00000L026EA92D 849010AW02 00000L3A482932 266150AW04 00000L3A70D09C 120810AW02 00000LA70A3DDF 788000AW02 00000L3AB6762A 00440ADW18 00000L3AB048FE 00440ADW15 00000LA70E6008 00327ADW03 00000L13050001 00133ADW02 0000AN12171004 00249ADW01 00000Q13092002 00000LA716AE5C 317338AW5 Class II GE Healthcare has recently become aware of a potential safety issue due to higher than actual flow values reported on CardiacVX and CardiacVX Flow running on Advantage Workstation. GE Healthcare, LLC
Biologics AllSet+" Gold SSP HLA- A*23/24 High Res Kit (54160D) A*23 SSP UniTray® Kit (471702) A*23 SSP UniTray® Kit with Taq Polymerase (471712) Product Name: AllSet+" Gold SSP HLA- A*23/24 High Res Kit 54160D Lot/serial: 002 1138827, 002 1256850, 002 1379885, 002 1504232; A*23 SSP UniTray® Kit 471702 Lot.Serial: 006 1078519,006 1160463, 006 1221255, 006 1399452; A*23 SSP UniTray® Kit with Taq Polymerase 471712, Lot/serial: 006 1078519. Class II HLA typing assay, associated with false typing assignments, was distributed. Life Technologies Corporation
Drugs Children's Triacting Night Time Cold & Cough with PE (diphenhydramine hcl and phenylephrine hcl), Grape Flavor, For Ages 6 to 11, 4 fl oz Bottles, liquid. Labeled A) aaron health KIDS, Manufactured by: Aaron Industries, P.O. Box 801, Lynwood, CA 90262. UPC: 7 15256 72204 9. B) FAMILY wellness, Distributed By: Family Dollar Services, Inc., 10401 Monroe Rd, Matthews, NC 28105. UPC: 0 32251 03394 0. C) Good Neighbor Pharmacy. Distributed By: AmerisourceBergen, 1300 Morris Drive, Chesterbrook, PA 19087. NDC: 24385-121-25. D) Pedia Care. Distributed by Medtech Products Inc., Irvington, NY 10533. UPC: 8 14832 01354 7. E) Quality Choice. Distributed by Quality Choice, Novi, MI 48376-0995. NDC: 63868-0368-04. F) Safeway. Distributed by Safeway Inc. P.O. Box 99, Pleasanton, CA 94566. NDC: 21130-152-04. G) Well at Walgreens. Distributed By: Walgreen Co, 200 Wilmot Rd., Deerfield, IL 60015. NDC: 0363-0152-04. Lot # (expiry): Aaron Health A) 73825 (6/14), 74141 (6/14), 74830 (6/14), 74898 (7/14), 75339 (7/14), 75455 (7/14), 78531 (9/14), 79050 (9/14), 79267 (10/14), 80017 (7/14), 80781 (7/14), 81121 (10/14), 82178 (10/14). FAMILY wellness B) 82312 (10/14), 82500 (10/15), 133197 (1/15), 140385 (1/15), 141937  ...
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Class III Presence of Precipitate: Small amounts of diphenydramine and mannitol precipitated out of solution. P&L Developments, LLC
Devices HexaPOD evo RT Couchtop. To support and aid in positioning a patient during radiation therapy. Serial Numbers  42188, 42246, 42106, 42153, 42107, 42068, 42012, 42013, 42062, 42009, 42224, 42126, 3005, 42222, 3019, 3000, 42058, 42059, 42057, 42187, 42129, 42159, 3022, 3017, 42189, 42213, 42202, 42212, 42004, 4220, 42113, 42178, 42216, 42207, 2982, 2986, 2991, 42102, 42000, 42032, 42145, 42174, 42008, 42048, 42064, 42070, 42074,  ...
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Class II If screws are not properly tightened with a torque wrench they may become loose over time. Elekta, Inc.
Drugs Glytone Acne, acne treatment facial cleanser, 2% Salicylic Acid, 200 mL/6.7 FL Oz Bottle, Distributed by Genesis Pharmaceuticals, Inc. a subsidiary of Pierre Fabre, Parsippany, NJ 07054, UPC 3 04760-00413-2 Lot 54, Exp: 1/14/2016 Class III Failed Stability Specifications: Out of specification results for viscosity in one lot of Glytone Acne Treatment Facial Cleanser. Genesis Pharmaceutical, Inc.
Devices GE Healthcare Discovery MR450, Discovery MR750, Optima MR450w, Optima MR450w equipped with the GEM option, Discovery MR750w, and Discovery MR750w equipped with the GEM option products. Affected devices are whole body magnetic resonance scanners indicated for use as a diagnostic imaging devices. Mfg Lot or Serial # SystemID 00001250FMM026 919684DMPMR1 00000301309MR1 6628 00000000HM0426 6947 00000305379MR0 7462 00001018XF503B 205592750 00001227FMM00T 201445750W 00000297006MR9 202476MR1 00000296307MR2 202476MR2 00000297727MR0 202476MR3 00000300562MR6 202476MR4 00000000UA0153 202966MR3TW 00000305414MR5 203739MR450W 00000301842MR1 203863MR450W 00001203FMMOUJ 205750MR5 00000298836MR8 205838MR4 00000298249MR4 205949MR450W 00000301841MR3 206292SR450W 00000000UA0026 206292SR750W 00000293338MR0 206CH750MR 00000295024MR4 207945MR750 00001250FMM033 207OA450WMR 00000305461MR6 208882MR450W  ...
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Class II GE Healthcare has recently become aware of a potential safety issue with certain GE MRI Products. Patient egress from the system can be delayed or impeded if the cradle release handle and/or cradle release block mechanism malfunctions or becomes misaligned. This could make the safe removal of the patient from the system difficult. GE Healthcare, LLC
Biologics Bone 84320180; 84320181; 84320182; 84320184; 84320185; 84320186; 84320194; 84320195; 84320196; 84320197; 84320198; 84320199; 84320200; 84320201; 84320202; 84320203; 84320204; 84320205; 84320206; 84320207; 84320208; 84320209; 84320210; 84320211; 84320212; 84320213; 84320214; 84320215; 84320216; 84320217; 84320218; 84320219; 84320220; 84320221; 84320222; 84320223; 84320224; 84320225; 84320226; 84320227; 84320228; 84320229; 84320187; 84320188; 84320189; 84320190; 84320191; 84320192; 84320193; 84320158;  ...
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Class III Human bone allografts, mislabeled with an extended expiration date, were distributed. University Of Miami Miller School of Medicine Tissue Bank
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