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U.S. Department of Health and Human Services

Enforcement Report - Week of August 22, 2012

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Event Detail

Event ID 62443
Product Type Drugs
Status Ongoing
Recalling Firm Franck's Lab Inc., d.b.a. Franck's Compounding Lab
City Ocala
State FL
Country US
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date 2012-05-21
Initial Firm Notification of
Consignee or Public
Letter
Distribution Pattern Nationwide, Bahamas, Columbia, Dominican Republic, Grand Cayman, Guatemala, Poland, Santo Domingo, Venezuela, West Indies

Product Detail

Product Description Code Info Classification Reason for Recall Product Quantity Recall Number
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. 87 units D-1628-2012
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. 13 units D-1627-2012
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. 5 units D-1626-2012
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. 4 units D-1625-2012
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. 6 units D-1623-2012
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. 26 units D-1622-2012
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. 17 units D-1621-2012
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. 11 units D-1620-2012
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. 4 units D-1619-2012
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. 24 units D-1618-2012
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. 1 unit D-1617-2012
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. 63 units D-1616-2012
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. 6 units D-1615-2012
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. 1 unit D-1614-2012
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. 3 units D-1613-2012
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. 3 units D-1612-2012
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. 19 units D-1611-2012
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. 110 units D-1610-2012
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. 10 units D-1609-2012
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. 8 units D-1608-2012
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. 8 units D-1607-2012
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. 1 unit D-1606-2012
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. 1 unit D-1605-2012
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. 18 units D-1604-2012
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. 5 units D-1602-2012
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. 5 units D-1601-2012
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. 1 unit D-1600-2012
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. 16 units D-1599-2012
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. 13 units D-1598-2012
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. 6 units D-1597-2012
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. 2 units D-1596-2012
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. 1 unit D-1595-2012
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. 2 units D-1594-2012
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. 1 unit D-1592-2012
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. 2 units D-1591-2012
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. 16 units D-1589-2012
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. 160 units D-1588-2012
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. 2 units D-1587-2012
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. 6 units D-1586-2012
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. 92 units D-1585-2012
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. 6 units D-1584-2012
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. 7 units D-1583-2012
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. 1 unit D-1582-2012
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. 1079 units D-1581-2012
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. 16 units D-1580-2012
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. 188 units D-1579-2012
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. 7 units D-1578-2012
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. 13 units D-1577-2012
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. 4 units D-1576-2012
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. 8 units D-1575-2012
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. D-1574-2012
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. 208 units D-1573-2012
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. 4 units D-1644-2012
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. 78 units D-1572-2012
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. 22 units D-1571-2012
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. 4 units D-1570-2012
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. 17 units D-1569-2012
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. 32 units D-1568-2012
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. 1 unit D-1567-2012
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. 25 units D-1642-2012
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. 38 units D-1641-2012
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. 7 units D-1566-2012
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. 6 units D-1565-2012
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. 1 unit D-1564-2012
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. 8 units D-1563-2012
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. 1 unit D-1562-2012
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. 11 units D-1561-2012
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. 15 units D-1560-2012
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. 20 units D-1559-2012
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. 8 units D-1640-2012
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. 5 units D-1639-2012
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. 224 units D-1638-2012
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. 434 units D-1558-2012
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. 1 unit D-1637-2012
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. 1193 units D-1636-2012
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. 2 units D-1557-2012
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. 7 units D-1556-2012
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. 102 units D-1634-2012
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. 6 units D-1633-2012
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. 1 unit D-1632-2012
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. 72 units D-1555-2012
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. 2 units D-1554-2012
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. 2 units D-1553-2012
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. 14 units D-1552-2012
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. 10 units D-1550-2012
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. 3 units D-1549-2012
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. 10 units D-1630-2012
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 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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. 1603 units D-1629-2012
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. 19 units D-1548-2012
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. 2 units D-1547-2012
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