Drug Recall Enforcement Reports
What are the Drug Enforcement Reports?
All drug recalls are monitored by the Food and Drug Administration (FDA) and are included in the Enforcement Report once they are properly classified. The FDA will determine if a firm's removal or correction actions of a marked product meet the requirements to be considered a "recall". The FDA will also determine the public hazard assessment and a recall classification will be published in the Enforcement Report.
The Drug Enforcement Reports included in this listing was last updated on August 07, 2026 and include a total of 17860 recall reports.
| Recall Number | Recall Initiation Date | Product Description | Recall Reason | Recall Firm / Quantity | Recall Classification | Status |
|---|---|---|---|---|---|---|
| D-1614-2012 | 05-21-2012 | RUBIDIUM 200MCG/ML INJECTABLE 30 ML (1 PRODUCT) | Lack of Assurance of Sterility: Franck's Lab Inc. initiated a recall of all Sterile Human Drugs distributed between 11/21/2011 and 05/21/2012. FDA environmental sampling revealed the presence of microorganisms and fungal growth in the clean room where sterile products were prepared. | Franck's Lab Inc., d.b.a. Franck's Compounding Lab / 1 unit | Class II | Terminated |
| D-1571-2012 | 05-21-2012 | 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) | Lack of Assurance of Sterility: Franck's Lab Inc. initiated a recall of all Sterile Human Drugs distributed between 11/21/2011 and 05/21/2012. FDA environmental sampling revealed the presence of microorganisms and fungal growth in the clean room where sterile products were prepared. | Franck's Lab Inc., d.b.a. Franck's Compounding Lab / 22 units | Class II | Terminated |
| D-1629-2012 | 05-21-2012 | 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 | Lack of Assurance of Sterility: Franck's Lab Inc. initiated a recall of all Sterile Human Drugs distributed between 11/21/2011 and 05/21/2012. FDA environmental sampling revealed the presence of microorganisms and fungal growth in the clean room where sterile products were prepared. | Franck's Lab Inc., d.b.a. Franck's Compounding Lab / 1603 units | Class II | Terminated |
| D-1563-2012 | 05-21-2012 | LIDOCAINE/TETRACAINE OPHTHALMIC 4%/0.5% SOLUTION 10 ML 15 ML 20 ML 200 ML 240 ML 300 ML 400 ML (7 DIFFERENT PRODUCTS) | Lack of Assurance of Sterility: Franck's Lab Inc. initiated a recall of all Sterile Human Drugs distributed between 11/21/2011 and 05/21/2012. FDA environmental sampling revealed the presence of microorganisms and fungal growth in the clean room where sterile products were prepared. | Franck's Lab Inc., d.b.a. Franck's Compounding Lab / 8 units | Class II | Terminated |
| D-1599-2012 | 05-21-2012 | 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) | Lack of Assurance of Sterility: Franck's Lab Inc. initiated a recall of all Sterile Human Drugs distributed between 11/21/2011 and 05/21/2012. FDA environmental sampling revealed the presence of microorganisms and fungal growth in the clean room where sterile products were prepared. | Franck's Lab Inc., d.b.a. Franck's Compounding Lab / 16 units | Class II | Terminated |
| D-1621-2012 | 05-21-2012 | 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 | Lack of Assurance of Sterility: Franck's Lab Inc. initiated a recall of all Sterile Human Drugs distributed between 11/21/2011 and 05/21/2012. FDA environmental sampling revealed the presence of microorganisms and fungal growth in the clean room where sterile products were prepared. | Franck's Lab Inc., d.b.a. Franck's Compounding Lab / 17 units | Class II | Terminated |
| D-1565-2012 | 05-21-2012 | LITHIUM CHLORIDE 5MG/ML INJECTABLE 30 ML (1 PRODUCT) | Lack of Assurance of Sterility: Franck's Lab Inc. initiated a recall of all Sterile Human Drugs distributed between 11/21/2011 and 05/21/2012. FDA environmental sampling revealed the presence of microorganisms and fungal growth in the clean room where sterile products were prepared. | Franck's Lab Inc., d.b.a. Franck's Compounding Lab / 6 units | Class II | Terminated |
| D-1586-2012 | 05-21-2012 | MOXIFLOXACIN 150MCG/0.1ML (1.5MG/ML) INJECTABLE 10 ML 20 ML (2 DIFFERENT PRODUCTS) | Lack of Assurance of Sterility: Franck's Lab Inc. initiated a recall of all Sterile Human Drugs distributed between 11/21/2011 and 05/21/2012. FDA environmental sampling revealed the presence of microorganisms and fungal growth in the clean room where sterile products were prepared. | Franck's Lab Inc., d.b.a. Franck's Compounding Lab / 6 units | Class II | Terminated |
| D-1638-2012 | 05-21-2012 | 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) | Lack of Assurance of Sterility: Franck's Lab Inc. initiated a recall of all Sterile Human Drugs distributed between 11/21/2011 and 05/21/2012. FDA environmental sampling revealed the presence of microorganisms and fungal growth in the clean room where sterile products were prepared. | Franck's Lab Inc., d.b.a. Franck's Compounding Lab / 224 units | Class II | Terminated |
| D-1637-2012 | 05-21-2012 | VANADYL SULFATE SOLUTION 200MCG/ML INJECTABLE 60 ML (1 PRODUCT) | Lack of Assurance of Sterility: Franck's Lab Inc. initiated a recall of all Sterile Human Drugs distributed between 11/21/2011 and 05/21/2012. FDA environmental sampling revealed the presence of microorganisms and fungal growth in the clean room where sterile products were prepared. | Franck's Lab Inc., d.b.a. Franck's Compounding Lab / 1 unit | Class II | Terminated |
| D-1635-2012 | 05-21-2012 | TWINJECT*** 0.3 MG INJECTABLE 1 PK (1 PRODUCT) | Lack of Assurance of Sterility: Franck's Lab Inc. initiated a recall of all Sterile Human Drugs distributed between 11/21/2011 and 05/21/2012. FDA environmental sampling revealed the presence of microorganisms and fungal growth in the clean room where sterile products were prepared. | Franck's Lab Inc., d.b.a. Franck's Compounding Lab / 1 unit | Class II | Terminated |
| D-1613-2012 | 05-21-2012 | RIBOFLAVIN SOLUTION 0.1% OPHTHALMIC 10 ML 5 ML; RIBOFLAVIN SOLUTION, P.F. 0.1% OPHTHALMIC 90 ML (3 DIFFERENT PRODUCTS) | Lack of Assurance of Sterility: Franck's Lab Inc. initiated a recall of all Sterile Human Drugs distributed between 11/21/2011 and 05/21/2012. FDA environmental sampling revealed the presence of microorganisms and fungal growth in the clean room where sterile products were prepared. | Franck's Lab Inc., d.b.a. Franck's Compounding Lab / 3 units | Class II | Terminated |
| D-1568-2012 | 05-21-2012 | 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) | Lack of Assurance of Sterility: Franck's Lab Inc. initiated a recall of all Sterile Human Drugs distributed between 11/21/2011 and 05/21/2012. FDA environmental sampling revealed the presence of microorganisms and fungal growth in the clean room where sterile products were prepared. | Franck's Lab Inc., d.b.a. Franck's Compounding Lab / 32 units | Class II | Terminated |
| D-1607-2012 | 05-21-2012 | 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) | Lack of Assurance of Sterility: Franck's Lab Inc. initiated a recall of all Sterile Human Drugs distributed between 11/21/2011 and 05/21/2012. FDA environmental sampling revealed the presence of microorganisms and fungal growth in the clean room where sterile products were prepared. | Franck's Lab Inc., d.b.a. Franck's Compounding Lab / 8 units | Class II | Terminated |
| D-1550-2012 | 05-21-2012 | ISOSULFAN BLUE 1% INJECTABLE 10 ML 15 ML (2 DIFFERENT PRODUCTS) | Lack of Assurance of Sterility: Franck's Lab Inc. initiated a recall of all Sterile Human Drugs distributed between 11/21/2011 and 05/21/2012. FDA environmental sampling revealed the presence of microorganisms and fungal growth in the clean room where sterile products were prepared. | Franck's Lab Inc., d.b.a. Franck's Compounding Lab / 10 units | Class II | Terminated |
| D-1624-2012 | 05-21-2012 | THERACYS, (BCG VACCINE) LIVE W/DILUENT** 81MG INJECTABLE 1 VIAL 1 VIALS 12 VIAL 12 VIALS 2 VIALS 3 VIALS 4 VIAL 4 VIALS 5 VIAL 5 VIALS 6 VIAL 6 VIALS 8 VIALS (13 DIFFERENT PRODUCTS) | Lack of Assurance of Sterility: Franck's Lab Inc. initiated a recall of all Sterile Human Drugs distributed between 11/21/2011 and 05/21/2012. FDA environmental sampling revealed the presence of microorganisms and fungal growth in the clean room where sterile products were prepared. | Franck's Lab Inc., d.b.a. Franck's Compounding Lab / 53 units | Class II | Terminated |
| D-1553-2012 | 05-21-2012 | LABETALOL HYDROCHLORIDE 5MG/ML INJECTABLE 100 ML 80 ML (2 DIFFERENT PRODUCTS) | Lack of Assurance of Sterility: Franck's Lab Inc. initiated a recall of all Sterile Human Drugs distributed between 11/21/2011 and 05/21/2012. FDA environmental sampling revealed the presence of microorganisms and fungal growth in the clean room where sterile products were prepared. | Franck's Lab Inc., d.b.a. Franck's Compounding Lab / 2 units | Class II | Terminated |
| D-1615-2012 | 05-21-2012 | SELENIUM 200MCG/ML INJECTABLE 150 ML 30 ML 60 ML (3 DIFFERENT PRODUCTS) | Lack of Assurance of Sterility: Franck's Lab Inc. initiated a recall of all Sterile Human Drugs distributed between 11/21/2011 and 05/21/2012. FDA environmental sampling revealed the presence of microorganisms and fungal growth in the clean room where sterile products were prepared. | Franck's Lab Inc., d.b.a. Franck's Compounding Lab / 6 units | Class II | Terminated |
| D-1578-2012 | 05-21-2012 | 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) | Lack of Assurance of Sterility: Franck's Lab Inc. initiated a recall of all Sterile Human Drugs distributed between 11/21/2011 and 05/21/2012. FDA environmental sampling revealed the presence of microorganisms and fungal growth in the clean room where sterile products were prepared. | Franck's Lab Inc., d.b.a. Franck's Compounding Lab / 7 units | Class II | Terminated |
| D-1559-2012 | 05-21-2012 | 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) | Lack of Assurance of Sterility: Franck's Lab Inc. initiated a recall of all Sterile Human Drugs distributed between 11/21/2011 and 05/21/2012. FDA environmental sampling revealed the presence of microorganisms and fungal growth in the clean room where sterile products were prepared. | Franck's Lab Inc., d.b.a. Franck's Compounding Lab / 20 units | Class II | Terminated |
| D-1605-2012 | 05-21-2012 | POVIDONE-IODINE/LIDOCAINE/TETRACAINE 4.6%/4%/0.5% OPHTHALMIC 30 ML (1 PRODUCT) | Lack of Assurance of Sterility: Franck's Lab Inc. initiated a recall of all Sterile Human Drugs distributed between 11/21/2011 and 05/21/2012. FDA environmental sampling revealed the presence of microorganisms and fungal growth in the clean room where sterile products were prepared. | Franck's Lab Inc., d.b.a. Franck's Compounding Lab / 1 unit | Class II | Terminated |
| D-1603-2012 | 05-21-2012 | POTASSIUM CHLORIDE ***(30ML VIAL) 2MEQ/ML INJECTABLE 750 MLS; POTASSIUM CHLORIDE IN NORMAL SALINE 40MEQ/100ML (400MEQ/L) INJECTABLE 1000 ML; POTASSIUM CHLORIDE**(25X20ML) 2MEQ/ML INJECTABLE 500 ML; POTASSIUM PHOSPHATE 4.4MEQ/ML (3MMOL/ML) INJECTABLE 300 ML 750 ML (5 DIFFERENT PRODUCTS) | Lack of Assurance of Sterility: Franck's Lab Inc. initiated a recall of all Sterile Human Drugs distributed between 11/21/2011 and 05/21/2012. FDA environmental sampling revealed the presence of microorganisms and fungal growth in the clean room where sterile products were prepared. | Franck's Lab Inc., d.b.a. Franck's Compounding Lab / 6 units | Class II | Terminated |
| D-1606-2012 | 05-21-2012 | PREDNISOLONE ACETATE 10MG/ML INJECTABLE 10 MLS (1 PRODUCT) | Lack of Assurance of Sterility: Franck's Lab Inc. initiated a recall of all Sterile Human Drugs distributed between 11/21/2011 and 05/21/2012. FDA environmental sampling revealed the presence of microorganisms and fungal growth in the clean room where sterile products were prepared. | Franck's Lab Inc., d.b.a. Franck's Compounding Lab / 1 unit | Class II | Terminated |
| D-1579-2012 | 05-21-2012 | 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) | Lack of Assurance of Sterility: Franck's Lab Inc. initiated a recall of all Sterile Human Drugs distributed between 11/21/2011 and 05/21/2012. FDA environmental sampling revealed the presence of microorganisms and fungal growth in the clean room where sterile products were prepared. | Franck's Lab Inc., d.b.a. Franck's Compounding Lab / 188 units | Class II | Terminated |
| D-1631-2012 | 05-21-2012 | TROCAR KIT, STERILE DISPOSABLE** DEVICE 1 KIT 1 PELLET 2 KIT 3 KIT 4 KIT 5 KITS 6 KIT (7 DIFFERENT PRODUCTS) | Lack of Assurance of Sterility: Franck's Lab Inc. initiated a recall of all Sterile Human Drugs distributed between 11/21/2011 and 05/21/2012. FDA environmental sampling revealed the presence of microorganisms and fungal growth in the clean room where sterile products were prepared. | Franck's Lab Inc., d.b.a. Franck's Compounding Lab / 64 units | Class II | Terminated |
| D-1604-2012 | 05-21-2012 | 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) | Lack of Assurance of Sterility: Franck's Lab Inc. initiated a recall of all Sterile Human Drugs distributed between 11/21/2011 and 05/21/2012. FDA environmental sampling revealed the presence of microorganisms and fungal growth in the clean room where sterile products were prepared. | Franck's Lab Inc., d.b.a. Franck's Compounding Lab / 18 units | Class II | Terminated |
| D-1548-2012 | 05-21-2012 | 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) | Lack of Assurance of Sterility: Franck's Lab Inc. initiated a recall of all Sterile Human Drugs distributed between 11/21/2011 and 05/21/2012. FDA environmental sampling revealed the presence of microorganisms and fungal growth in the clean room where sterile products were prepared. | Franck's Lab Inc., d.b.a. Franck's Compounding Lab / 19 units | Class II | Terminated |
| D-1623-2012 | 05-21-2012 | TETRACOSACTIDE ACETATE (COSYNTROPIN) 0.25MG/ML INJECTABLE 1 ML (1 PRODUCT) | Lack of Assurance of Sterility: Franck's Lab Inc. initiated a recall of all Sterile Human Drugs distributed between 11/21/2011 and 05/21/2012. FDA environmental sampling revealed the presence of microorganisms and fungal growth in the clean room where sterile products were prepared. | Franck's Lab Inc., d.b.a. Franck's Compounding Lab / 6 units | Class II | Terminated |
| D-1611-2012 | 05-21-2012 | 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) | Lack of Assurance of Sterility: Franck's Lab Inc. initiated a recall of all Sterile Human Drugs distributed between 11/21/2011 and 05/21/2012. FDA environmental sampling revealed the presence of microorganisms and fungal growth in the clean room where sterile products were prepared. | Franck's Lab Inc., d.b.a. Franck's Compounding Lab / 19 units | Class II | Terminated |
| D-1630-2012 | 05-21-2012 | 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) | Lack of Assurance of Sterility: Franck's Lab Inc. initiated a recall of all Sterile Human Drugs distributed between 11/21/2011 and 05/21/2012. FDA environmental sampling revealed the presence of microorganisms and fungal growth in the clean room where sterile products were prepared. | Franck's Lab Inc., d.b.a. Franck's Compounding Lab / 10 units | Class II | Terminated |
| D-1585-2012 | 05-21-2012 | 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) | Lack of Assurance of Sterility: Franck's Lab Inc. initiated a recall of all Sterile Human Drugs distributed between 11/21/2011 and 05/21/2012. FDA environmental sampling revealed the presence of microorganisms and fungal growth in the clean room where sterile products were prepared. | Franck's Lab Inc., d.b.a. Franck's Compounding Lab / 92 units | Class II | Terminated |
| D-1556-2012 | 05-21-2012 | 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) | Lack of Assurance of Sterility: Franck's Lab Inc. initiated a recall of all Sterile Human Drugs distributed between 11/21/2011 and 05/21/2012. FDA environmental sampling revealed the presence of microorganisms and fungal growth in the clean room where sterile products were prepared. | Franck's Lab Inc., d.b.a. Franck's Compounding Lab / 7 units | Class II | Terminated |
| D-1619-2012 | 05-21-2012 | STRONTIUM 1 MG/ML INJECTABLE 30 ML 60 ML (2 DIFFERENT PRODUCTS) | Lack of Assurance of Sterility: Franck's Lab Inc. initiated a recall of all Sterile Human Drugs distributed between 11/21/2011 and 05/21/2012. FDA environmental sampling revealed the presence of microorganisms and fungal growth in the clean room where sterile products were prepared. | Franck's Lab Inc., d.b.a. Franck's Compounding Lab / 4 units | Class II | Terminated |
| D-1625-2012 | 05-21-2012 | THIAMINE HCL 100MG/ML INJECTABLE 300 ML 360 ML 450 ML (3 DIFFERENT PRODUCTS) | Lack of Assurance of Sterility: Franck's Lab Inc. initiated a recall of all Sterile Human Drugs distributed between 11/21/2011 and 05/21/2012. FDA environmental sampling revealed the presence of microorganisms and fungal growth in the clean room where sterile products were prepared. | Franck's Lab Inc., d.b.a. Franck's Compounding Lab / 4 units | Class II | Terminated |
| D-1612-2012 | 05-21-2012 | RANITIDINE 25MG/ML INJECTABLE 200 ML 480 ML 800 ML (3 DIFFERENT PRODUCTS) | Lack of Assurance of Sterility: Franck's Lab Inc. initiated a recall of all Sterile Human Drugs distributed between 11/21/2011 and 05/21/2012. FDA environmental sampling revealed the presence of microorganisms and fungal growth in the clean room where sterile products were prepared. | Franck's Lab Inc., d.b.a. Franck's Compounding Lab / 3 units | Class II | Terminated |
| D-1592-2012 | 05-21-2012 | PANTOTHENIC ACID 1MG/ML INJECTABLE 30 ML (1 PRODUCT) | Lack of Assurance of Sterility: Franck's Lab Inc. initiated a recall of all Sterile Human Drugs distributed between 11/21/2011 and 05/21/2012. FDA environmental sampling revealed the presence of microorganisms and fungal growth in the clean room where sterile products were prepared. | Franck's Lab Inc., d.b.a. Franck's Compounding Lab / 1 unit | Class II | Terminated |
| D-1560-2012 | 05-21-2012 | 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) | Lack of Assurance of Sterility: Franck's Lab Inc. initiated a recall of all Sterile Human Drugs distributed between 11/21/2011 and 05/21/2012. FDA environmental sampling revealed the presence of microorganisms and fungal growth in the clean room where sterile products were prepared. | Franck's Lab Inc., d.b.a. Franck's Compounding Lab / 15 units | Class II | Terminated |
| D-1609-2012 | 05-21-2012 | PYRIDOXINE 100MG/ML INJECTABLE 150 ML 180 ML 300 ML 360 ML 450 ML (5 DIFFERENT PRODUCTS) | Lack of Assurance of Sterility: Franck's Lab Inc. initiated a recall of all Sterile Human Drugs distributed between 11/21/2011 and 05/21/2012. FDA environmental sampling revealed the presence of microorganisms and fungal growth in the clean room where sterile products were prepared. | Franck's Lab Inc., d.b.a. Franck's Compounding Lab / 10 units | Class II | Terminated |
| D-1555-2012 | 05-21-2012 | 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) | Lack of Assurance of Sterility: Franck's Lab Inc. initiated a recall of all Sterile Human Drugs distributed between 11/21/2011 and 05/21/2012. FDA environmental sampling revealed the presence of microorganisms and fungal growth in the clean room where sterile products were prepared. | Franck's Lab Inc., d.b.a. Franck's Compounding Lab / 72 units | Class II | Terminated |
| D-1643-2012 | 05-21-2012 | WATER BACT STERILE - (25X30ML)*** INJECTABLE 30 ML 750 MLS; WATER STERILE - USP (25X10ML)* INJECTABLE 10 ML 10 MLS 100 ML 100 MLS 1000 ML 110 ML 120 ML 130 ML 130 MLS 150 150 ML 150 MLS 160 ML 160 MLS 20 20 ML 200 ML 200 MLS 2000 ML 230 ML 240 ML 250 ML 250 MLS 30 ML 30 MLS 300 300 ML 300 MLS 40 ML 40 MLS 400 ML 400 MLS 50 50 ML 50 MLS 500 ML 500 MLS 60 60 ML 60 MLS 6800 ML 70 ML 7240 ML 7500 ML 80 ML 80 MLS 90 ML; WATER STERILE - USP (25X20ML)** INJECTABLE 1000 MLS 200 ML 200 MLS 300 MLS 400 MLS 500 ML 60 60 ML 600 20 600 ML; WATER STERILE - USP (25X50ML)** INJECTABLE 1000 ML 1150 ML 1250 MLS 1350 ML 150 MLS 2500 ML 300 ML 50 ML 500 ML 500 MLS 600 600 ML 600 MLS (72 DIFFERENT PRODUCTS) | Lack of Assurance of Sterility: Franck's Lab Inc. initiated a recall of all Sterile Human Drugs distributed between 11/21/2011 and 05/21/2012. FDA environmental sampling revealed the presence of microorganisms and fungal growth in the clean room where sterile products were prepared. | Franck's Lab Inc., d.b.a. Franck's Compounding Lab / 311 units | Class II | Terminated |
| D-1580-2012 | 05-21-2012 | 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) | Lack of Assurance of Sterility: Franck's Lab Inc. initiated a recall of all Sterile Human Drugs distributed between 11/21/2011 and 05/21/2012. FDA environmental sampling revealed the presence of microorganisms and fungal growth in the clean room where sterile products were prepared. | Franck's Lab Inc., d.b.a. Franck's Compounding Lab / 16 units | Class II | Terminated |
| D-1387-2012 | 05-21-2012 | Hands Down Medicated Lotion Soap, 1 gallon bottle, 4 gallons per case, Distributed by PCS Industries, Crestwood, IL, 60446 | Labeling: Presence of Undeclared Additive: Medicated lotion soap produced and distributed by the recalling firm contains the unapproved ingredient, Red Dye #15. This dye is not approved for use in food, drugs or cosmetics. | Kutol Products Co Inc / 11,688 gallon bottles (2,922 cases) | Class II | Terminated |
| D-326-2013 | 05-18-2012 | a) Firminite 805 mg is packaged in 2 count, 4 count, and 10 count capsules blister packs in a box, WWW.FIRMINITE.COM, b) Libidron 410 mg is packaged in 2 count, 4 count, and 10 count capsules blister packs in a box, WWW.LIBIDRON.COM , c)Extra Strength Instant Hot Rod 496 mg is packaged in 4 count and 10 count capsule blister packs in a box, www.HotRodExtraStrength.com | Marketed Without an Approved NDA/ANDA: These products found to contain undeclared tadalafil. Tadalafil is an FDA-approved drug for the treatment of male Erectile Dysfunction (ED), making these products unapproved new drugs. | InSo-Independent Contractor for West Coast Nutritionals,LTD / 8,000 blister packs | Class I | Terminated |
| D-1442-2012 | 05-18-2012 | Copaxone (glatiramer acetate injection), 20mg/mL, 1 mL , Rx only, Marketed by: Teva Neuroscience - NDC 68546-317-30 Package NDCs: 68546-317-00; 68546-317-30; 68546-325-06; 68546-325-12 | Presence of Foreign Substance: Recall is being initiated due to the presence of a foreign particle identified from a customer complaint. | Teva Pharmaceuticals USA, Inc. / 6,647 cartons | Class II | Terminated |
| D-1404-2012 | 05-17-2012 | Imodium Multi-Symptom Relief Caplets, Loperamide HCl 2 mg/Simethicone 125 mg, 18 count blister pack cartons, McNeil Consumer Healthcare, Div of McNeil-PPC Inc., Fort Washington, PA | Defective Container; damaged blister units | Mcneil Consumer Healthcare, Div Of Mcneil-ppc, Inc. / 53,892 packages | Class III | Terminated |
| D-1409-2012 | 05-16-2012 | Metoprolol Tartrate Tablets USP 50 mg, 1000 count bottle, Rx only, Manufactured in india By: Emcure Pharmaceuticals LTD. Hinjwadi, Pune, India, Manufactured for TEVA Phamaceuticals USA, Sellersville, PA 18960, NDC 0093-0733-10 | Tablet Thickness: Potential for some tablets not conforming to weight specifications (under and over weight) | Teva Pharmaceuticals USA, Inc. / 2,268 bottles | Class II | Terminated |
| D-1388-2012 | 05-14-2012 | Zemplar (paricalcitol) Injection, 5 mcg/mL in 2 mL multi-dose vials, 25 vial carton, Rx only, Manufactured by Hospira, Inc. For Abbott Laboratories, North Chicago, IL 60064, USA, NDC 0074-1658-05 Package NDCs: 0074-4637-01; 0074-1658-01; 0074-1658-05 | CGMP Deviations: There is potential that Abbott's third party manufacturer, Hospira, may have applied a foreign (incorrect) stopper to vials in a specific lot of Zemplar Injection. | Abbott Laboratories / 121,000 vials | Class II | Terminated |
| D-1444-2012 | 05-12-2012 | HYDROmorphone HCl Injection, USP, 1 mg/mL, 1 mL fill in a 2.5 mL Carpuject prefilled cartridge unit, packaged in 10-count Carpujects per carton, Rx only, Hospira, Inc., Lake Forest, IL 60045, NDC 0409-1283-31, Barcode (01) 1 030409 128331 9 (carton), (01) 0 030409 128331 2 (cartridge unit). Package NDCs: 0409-2552-11; 0409-2552-01; 0409-3356-11; 0409-3356-01; 0409-2540-11; 0409-2540-01; 0409-3365-11; 0409-3365-01; 0409-3365-10; 0409-1283-03; 0409-1283-31; 0409-1312-03; 0409-1312-30; 0409-1304-03; 0409-1304-31 | Superpotent (Single Ingredient) Drug: Some of the prefilled cartridge units have been found to be overfilled and contain more than the 1 mL labeled fill volume. | Hospira Inc. / 223,750 prefilled cartridge units | Class I | Terminated |
| D-1425-2012 | 05-09-2012 | Dent's Extra Strength Toothache Gum, (benzocaine 20%), Net Wt. .035 Oz.. (1 g) box, C.S. Dent & Co., Erlanger, KY | Superpotent; benzocaine | Grandpa Brands Co / Lot #C2501: 18150 pieces of gum (1 per package); Lot #B2111: 18129 pieces of gum (1 per package) | Class II | Terminated |
| D-1647-2012 | 05-08-2012 | Derma-Smoothe/FS (Fluocinolone Acetonide) 0.01%, Body Oil, 4 fl. oz. (118.28mL ), Rx only, FOR TOPICAL USE ONLY, Manufactured and Distributed by: Hill Dermaceuticals, Inc. SANFORD, FLORIDA --- NDC 28105-150-04 | Subpotent; fluocinolone acetonide | Hill Dermaceuticals, Inc. / 111,816 bottles | Class III | Terminated |
| D-1646-2012 | 05-08-2012 | Derma-Smoothe/FS (Fluocinolone Acetonide) 0.01% Topical Oil (Scalp Oil), 4 fl oz (118.28mL) bottle, Rx only, FOR TOPICAL USE ONLY NOT, Manufactured and Distributed by: Hill Dermaceuticals, Inc. SANFORD, FLORIDA --- NDC 28105-149-04 | Subpotent; fluocinolone acetonide | Hill Dermaceuticals, Inc. / 161,064 bottles | Class III | Terminated |
| D-1433-2012 | 05-08-2012 | Estradiol Hemihydrate M20 EP/USP Powder, packaged in a) 1.5 kg and b) 2.5 kg fiber drums, Rx only, Art. No. 165811, Bayer Pharma AG, D-13342 Berlin. | Cross Contamination w/Other Products: This active pharmaceutical ingredient is being recalled due to cross contamination with another product. | Bayer HealthCare Pharmaceuticals Inc. / 112.295 kg | Class II | Terminated |
| D-1656-2012 | 05-08-2012 | Morton, Sodium Chloride, USP, Granular, packaged in kraft paper bags, fiber drums, and semi-bulk bags. Product is shipped in 80 lb bags, 350 lb drums & 2000 lb semi-bulk sacks. Manufactured by Morton Salt, Inc., Chicago, Illinois 60606-1743. | Impurities/Degradation Products: The product was found to contain a slightly out of specification level of bromides, exceeding the bromides limit for USP Sodium Chloride. | Morton Salt Co. / 531,950 lbs | Class III | Terminated |
| D-0002-2016 | 05-07-2012 | Rodan & Fields Proactiv Solution, Sheer Finish Compact Foundation, salicylic acid acne treatment, LIGHT, 7 g/0.25 OZ. Compacts, Over the Counter. Manufactured for Guthy-Renker Palm Desert, CA 92250. | Subpotent Drug: Salicylic acid is subpotent. | Guthy-Renker LLC / 29,341 Compacts | Class III | Terminated |
| D-0005-2016 | 05-07-2012 | Rodan & Fields Proactiv Solution, Sheer Finish Compact Foundation, salicylic acid acne treatment, DARK, 7 g/0.25 OZ. Compacts, Over the Counter. Manufactured for Guthy-Renker Palm Desert, CA 92250. | Subpotent Drug: Salicylic acid is subpotent. | Guthy-Renker LLC / 2,537 Compacts | Class III | Terminated |
| D-0004-2016 | 05-07-2012 | Rodan & Fields Proactiv Solution, Sheer Finish Compact Foundation, salicylic acid acne treatment, TAN, 7 g/0.25 OZ. Compacts, Over the Counter. Manufactured for Guthy-Renker Palm Desert, CA 92250. | Subpotent Drug: Salicylic acid is subpotent. | Guthy-Renker LLC / 4,526 Compacts | Class III | Terminated |
| D-0003-2016 | 05-07-2012 | Rodan & Fields Proactiv Solution, Sheer Finish Compact Foundation, salicylic acid acne treatment, MEDIUM, 7 g/0.25 OZ. Compacts, Over the Counter. Manufactured for Guthy-Renker Palm Desert, CA 92250. | Subpotent Drug: Salicylic acid is subpotent. | Guthy-Renker LLC / 5,025 Compacts | Class III | Terminated |
| D-1381-2012 | 05-07-2012 | Endocet (oxycodone and acetaminophen) tablets, USP, 10 mg/650 mg, 100-count tablets per bottle, Rx only, Manufactured for: Endo Pharmaceuticals Inc., Chadds Ford, PA, By: Novartis, Lincoln, NE 68501; NDC 60951-797-70. | Adulterated Presence of Foreign Tablets: Customer complaint that some Endocet 10 mg/325 mg tablets were found mixed in a bottle with Endocet 10 mg/650 mg tablets. | Endo Pharmaceuticals, Inc. / 11,764 bottles | Class III | Terminated |
| D-0001-2016 | 05-07-2012 | Rodan & Fields Proactiv Solution, Sheer Finish Compact Foundation, salicylic acid acne treatment, FAIR, 7 g/0.25 OZ. Compacts, Over the Counter. Manufactured for Guthy-Renker Palm Desert, CA 92250. | Subpotent Drug: Salicylic acid is subpotent. | Guthy-Renker LLC / 9,960 Compacts | Class III | Terminated |
| D-613-2013 | 05-04-2012 | 0.45% Sodium Chloride Injection, USP, Rx Only, 250 mL, by Hospira, Inc., Lake Forest, IL 60045, NDC 0409-7132-02 Package NDCs: 0409-7101-68; 0409-7101-66; 0409-7101-69; 0409-7101-67; 0409-7101-04; 0409-7101-02; 0409-7132-68; 0409-7132-66; 0409-7132-69; 0409-7132-67; 0409-7132-04; 0409-7132-02 | Lack of Assurance of Sterility: Hospira, Inc is voluntarily recalling the products due to possible leaking bags. | Hospira Inc. / 136,584 units | Class II | Terminated |
| D-612-2013 | 05-04-2012 | 70% Dextrose Injection USP, 2000 mL, Rx Only, by Hospira, Inc., Lake Forest, IL 60045, NDC 0409-7120-07 | Lack of Assurance of Sterility: Hospira, Inc is voluntarily recalling the products due to possible leaking bags. | Hospira Inc. / 14,706 units | Class II | Terminated |
| D-615-2013 | 05-04-2012 | 5% Dextrose and 0.45% Sodium Chloride Injection, USP, 1000 mL VisIV Container, Hospira, Inc., Lake Forest, IL 60045, NDC 0409-7926-48 | Lack of Assurance of Sterility: Hospira, Inc is voluntarily recalling the products due to possible leaking bags. | Hospira Inc. / 74,256 units | Class II | Terminated |
| D-611-2013 | 05-04-2012 | 0.9% Sodium Chloride Injection, USP, Polyolefin Flexible Container, a) 500 mL (NDC 0409-7983-30), b) 1000 mL (NDC 0409-7983-48), c) 250 mL (NDC 0409-7983-02), d) 150 mL (NDC 0409-7983-61), Rx Only, by Hospira, Inc., Lake Forest, IL 60045 | Lack of Assurance of Sterility: Hospira, Inc is voluntarily recalling the products due to possible leaking bags. | Hospira Inc. / 2,137,660 units | Class II | Terminated |
| D-618-2013 | 05-04-2012 | 1.5% Glycine Irrigation, USP, 3000 mL, Rx Only, Hospira, Inc., Lake Forest, IL 60045 NDC 0409-7974-08 | Lack of Assurance of Sterility: Hospira, Inc is voluntarily recalling the products due to possible leaking bags. | Hospira Inc. / 40,988 units | Class II | Terminated |
| D-617-2013 | 05-04-2012 | 0.9% Sodium Chloride Irrigation, USP, 3000 mL, Rx Only, Hospira, Inc., Lake Forest, IL 60045, NDC 0409-7972-08 | Lack of Assurance of Sterility: Hospira, Inc is voluntarily recalling the products due to possible leaking bags. | Hospira Inc. / 98,084 units | Class II | Terminated |
| D-1383-2012 | 05-04-2012 | LifeGas OXYGEN COMPRESSED UN1072 USP, Distributed by: Linde | CGMP Deviations: The pressure gages, vacuum gages, and thermometer had surpassed the calibration expiry period, which may have resulted in overfill/underfill of oxygen cylinders. | Linde Gas LLC / 283 cylinders | Class II | Terminated |
| D-616-2013 | 05-04-2012 | 20% Dextrose Injection, USP, a) 500 mL in 1000 mL Partial-Fill Container (NDC 0409-7935-19), b) 500 mL VisIV Container (NDC 0409-7953-30), c) 1000 mL VisIV Container, (NDC 0409-7953-48), Rx Only, Hospira, Inc., Lake Forest, IL 60045 | Lack of Assurance of Sterility: Hospira, Inc is voluntarily recalling the products due to possible leaking bags. | Hospira Inc. / 216,396 units | Class II | Terminated |
| D-614-2013 | 05-04-2012 | 5% Dextrose Injection USP, a) 250 mL (NDC 0409-7922-02), b) 500 mL (NDC 0409-7922-30), by Hospira, Inc., Lake Forest, IL 60045 | Lack of Assurance of Sterility: Hospira, Inc is voluntarily recalling the products due to possible leaking bags. | Hospira Inc. / 267,288 units | Class II | Terminated |
| D-619-2013 | 05-04-2012 | 0.9% Sodium Chloride Injection, USP, a) 50 mL (NDC 0409-7984-13), b) 50 mL (NDC 0409-7984-36), c) 100 mL (0409-7984-37), Rx Only, Hospira, Inc., Lake Forest, IL 60045 | Lack of Assurance of Sterility: Hospira, Inc is voluntarily recalling the products due to possible leaking bags. | Hospira Inc. / 2,933,936 units | Class II | Terminated |
| D-1397-2012 | 05-02-2012 | Zeosa (norethindrone and ethinyl estradiol tablets USP, (chewable), 0.4 mg/0.035 mg, and ferrous fumarate tablets USP, (chewable) 75 mg), 3 Blister Cards, 28 Tablets Each, Rx only, TEVA Pharmaceuticals USA, Sellersville, PA 18960, NDC 0093-2090-28 and 0093-2090-58, cartons containing three (3) individual blister packs | Impurities/Degradation: This recall is being carried out due to the potential for some lots not meeting impurity specifications. | Teva Pharmaceuticals USA, Inc. / 100,761 cartons | Class II | Terminated |
| D-1377-2012 | 05-01-2012 | Octreotide Acetate Injection, 50 mcg/mL (0.05 mg/mL), 1 mL single dose vials, packaged in 10 x 1 mL single dose vials per pack, Rx only, Manufactured for: Bedford Laboratories, Bedford, OH 44146; Manufactured by: Ben Venue Laboratories, Inc., Bedford, OH 44146; NDC 55390-160-10; UPC 3 55390-160-10 1. | Short Fill: These products are being recalled because there is potential that vials with low fill volume were released into distribution. | Ben Venue Laboratories Inc / 6,515 packs | Class II | Terminated |
| D-1376-2012 | 05-01-2012 | Midazolam HCl Injection, 5 mg/mL, 1 mL single use vials, packaged in 10 x 1 mL single use vials per pack, Rx only, Manufactured by: Ben Venue Laboratories, Inc., Bedford, OH 44146; Manufactured for: Bedford Laboratories, Bedford, OH 44146, NDC 55390-138-01; UPC 3 55390-138-01 8. | Short Fill: These products are being recalled because there is potential that vials with low fill volume were released into distribution. | Ben Venue Laboratories Inc / 11,161 packs | Class II | Terminated |
| D-1439-2012 | 04-30-2012 | Dorzolamide HCI/Timolol Maleate Ophthalmic Solution 22.3mg/6.8mg per mL, 10mL bottle, For Topical Application in the Eye, Sterile Ophthalmic Solution, Rx Only, Mfg by: Apotex Inc., Toronto, Ontario, Canada M9L 1T9 | Presence of Particulate Matter: Lots identified in this recall notification may contain small particulates. | Apotex Inc. / 119,794 Bottles | Class II | Terminated |
| D-1423-2012 | 04-26-2012 | Midol Complete, Acetaminophen, Caffeine, Pyrilamine Maleate, Gelcaps 24 ct. blister, OTC, Distributed by Bayer Health Care, Morristown, NJ 07962 NDC 0280-8015-24 Package NDCs: 0280-8015-24 | Labeling: Label Mix-up: This recall was initiated after identifying that the label statement on the blister strip regarding the maximum number of capsules/caplets that should be taken within a 24-hour period, does not match the statement on the carton. | Bayer Healthcare, LLC / 119,412 cartons | Class III | Terminated |
| D-1424-2012 | 04-26-2012 | Midol Complete, Acetaminophen, Caffeine, Pyrilamine Maleate, Caplets, OTC, a) 16 ct. blister (NDC 0280-8005-16), b)24 ct. blister, Distributed by Bayer Health Care, Morristown, NJ 07962 (NDC 0280-8005-25) Package NDCs: 0280-8005-16; 0280-8005-24; 0280-8005-40; 0280-8005-01; 0280-8005-02; 0280-8005-04; 0280-8005-25 | Labeling: Label Mix-up: This recall was initiated after identifying that the label statement on the blister strip regarding the maximum number of capsules/caplets that should be taken within a 24-hour period, does not match the statement on the carton. | Bayer Healthcare, LLC / 48,528 cartons | Class III | Terminated |
| D-128-2013 | 04-24-2012 | CABERGOLINE Tablets, 0.5 mg, RX only, 8 count bottles, Manufactured For: TEVA PHARMACEUTICALS USA, Sellersville, PA 18960 NDC 0093-5420-88 Package NDCs: 0093-5420-88 | Impurities/Degradation Products: This lot of product will not meet the impurity specification over shelf life | Teva Pharmaceuticals USA, Inc. / 13,232 bottles | Class III | Terminated |
| D-1421-2012 | 04-24-2012 | Epinephrine Injection, USP, 1:1000 (1 mg/mL), 25 x 1 mL Ampules, For SC and IM Use, For IV and IC Use after Dilution, Rx Only, American Regent, Inc., Shirely, NY 11967 --NDC 0517-1071-25 | Presence of Particulate Matter | Luitpold Pharmaceuticals, Inc. / 63,750 ampules | Class II | Terminated |
| D-004-2013 | 04-23-2012 | ChloraPrep One-Step (2% w/v chlorhexidine gluconate and 70% v/v isopropyl alcohol) Patient Preoperative Skin Preparation, 3mL Applicators, 25 Applicators per Carton, Single Use, Latex Free, Applicator is STERILE if package is intact, NDC 54365-400-01. | Lack of Assurance of Sterility: Firm mistakenly released quarantined, non conforming material that failed sterility testing. | Carefusion 213, Llc / 576 Cartons | Class II | Terminated |
| D-1384-2012 | 04-23-2012 | Jolessa (levonorgestrel/ethinyl estradiol tablets, USP) 0.15 mg/0.03 mg, each Dispenser contains 91 tablets, 91 Day Regimen, Rx Only, Shaping Women's Health, Manufactured by: Barr Laboratories, Inc., Pomona, NY 10970, Manufactured for: Teva Pharmaceuticals USA, Sellersville, PA 18960, NDC 0555-9123-66. Package NDCs: 0555-9123-66 | Contraceptive Tablets Out of Sequence: This recall has been initiated due to the potential that some regimen packages may not contain placebo tablets. | Teva Pharmaceuticals USA, Inc. / 40,750 Dispensers | Class III | Terminated |
| D-037-2013 | 04-21-2012 | X-ROCK For Men, Dietary Supplement, Manufactured by CRM Laboratories, Distributed by XRock Industries, PO Box 120863, Ft. Lauderdale, FL 33312, 0 00309 50792 7. UPC on labeling is: 0 00309 50792 7. UPC in Press Release is: 0030950792. | Marketed Without an Approved NDA/ANDA: product tested positive for PDE-5 Sildenafil and PDE-5 Hydroxythiohomosildenafil. Hydroxythiohomosildenafil is an analog of sildenafil, an FDA approved prescription drug for Erectile Dysfunction (ED). | XRock Industries, LLC / 215,000 capsules | Class I | Terminated |
| D-1399-2012 | 04-17-2012 | Loxapine Capsules USP, 5mg, 100 count bottle, Rx only Manufactured By: Watson Laboratories Inc., Corona, CA 92880 NDC # 00591-0369-01. | Labeling: Incorrect or Missing Package Insert: An outdated version of a patient outsert was used when packaged. | Watson Laboratories Inc / 8254 bottles | Class III | Terminated |
| D-1403-2012 | 04-17-2012 | Loxitane Capsules, Loxapine Succinate Capsules, 10mg base, 100 count bottle, Rx only, Watson Laboratories Inc., Corona, CA 92880 NDC # 52544-495-01 | Labeling: Incorrect or Missing Package Insert: An outdated version of a patient outsert was used when packaged. | Watson Laboratories Inc / 7,262 bottles | Class III | Terminated |
| D-1419-2012 | 04-17-2012 | Morphine Sulfate Injection, USP, 4mg/mL, 1 mL fill in 2.5 mL Carpuject Cartridge Unit with Luer Lock, packaged 10 Carpujects/carton, CII, Rx only, Hospira, Inc., Lake Forest, IL ---- NDC 0409-1258-30 | Superpotent; Cartridges labeled to contain 1 mL found to contain 2.2 mL | Hospira Inc. / 212,370 cartidges | Class I | Terminated |
| D-1400-2012 | 04-17-2012 | Loxapine Capsules USP, 10mg, 100 count bottle, Rx only, Manufactured By: Watson Laboratories Inc., Corona, CA 92880 Rx only. NDC # 0591-0370-01 Package NDCs: 0591-0369-01; 0591-0370-01; 0591-0371-01; 0591-0372-01 | Labeling: Incorrect or Missing Package Insert: An outdated version of a patient outsert was used when packaged. | Watson Laboratories Inc / 106,323 bottles | Class III | Terminated |
| D-1402-2012 | 04-17-2012 | Loxapine Capsules USP, 50mg, 100 count bottle, Rx only Manufactured By: Watson Laboratories Inc., Corona, CA 92880 NDC # 0591-0372-01 Package NDCs: 0591-0369-01; 0591-0370-01; 0591-0371-01; 0591-0372-01 | Labeling: Incorrect or Missing Package Insert: An outdated version of a patient outsert was used when packaged. | Watson Laboratories Inc / 18,902 bottles | Class III | Terminated |
| D-1401-2012 | 04-17-2012 | Loxapine Capsules USP, 25mg, 100 count bottle, Rx only, Manufactured By: Watson Laboratories Inc., Corona, CA 92880 NDC # 0591-0371-01 Package NDCs: 0591-0369-01; 0591-0370-01; 0591-0371-01; 0591-0372-01 | Labeling: Incorrect or Missing Package Insert: An outdated version of a patient outsert was used when packaged. | Watson Laboratories Inc / 21,572 bottles | Class III | Terminated |
| D-1665-2012 | 04-16-2012 | Multihance Multipack (gadobenate dimeglumine) injection, 529 mg/mL, Pharmacy Bulk Package - Not for Direct Infusion, For Intravenous Use, Rx only, a) 50 mL Single Dose Vial, b) 100 mL Single Dose Vial, Manufactured for: Bracco Diagnostics Inc. Princeton, NJ 08543 by Nycomed GmbH, 78224 Singen (Germany), NDC a) 0270-5264-16, b) 0270-5264-17. Package NDCs: 0270-5264-16; 0270-5264-17 | Lack of Assurance of Sterility; Product recalled due to displacement of the aluminum crimp cap during product usage. | Bracco Diagnostics Inc / 4,870 Vials | Class II | Terminated |
| D-1663-2012 | 04-16-2012 | Bracco Diagnostics multihance (gadobenate dimeglumine) injection, 529 mg/mL, 20ml, Rx only, Manufactured for: Bracco Diagnostics Inc., Princeton, NJ 08543 USA, NDC 0270-5164-15 Package NDCs: 0270-5164-12; 0270-5164-13; 0270-5164-14; 0270-5164-15 | Short Fill: The product is being recalled due to a potential underfill of the affected vials. | Bracco Diagnostics Inc / 47,750 vials | Class III | Terminated |
| D-1437-2012 | 04-13-2012 | Fosphenytoin Sodium Injection, USP, 100 mg PE per 2 mL (50 mg PE per mL), 2 mL Single Dose Vial, packaged in 25-count x 2 mL Single Dose Vials per carton, Rx only, Mfd. By: Hikma Farmaceutica (Portugal), S.A.; Dist. By: West-Ward Pharmaceutical Corp., Eatontown, NJ 07724 USA under the labels a) NOVAPLUS (NDC 0143-9704-25), b) West-Ward (NDC 0143-9788-25). Package NDCs: 0143-9788-01; 0143-9788-25; 0143-9782-01; 0143-9782-10; 0143-9704-25 | Presence of Particulate Matter: This product is being recalled due to the discovery of particles in the stability samples and retain samples. | West-ward Pharmaceutical Corp. / a) 308,275 vials; b) 2,008,850 vials | Class II | Terminated |
| D-1438-2012 | 04-13-2012 | Fosphenytoin Sodium Injection, USP, 500 mg PE per 10 mL (50 mg PE per mL), 10 mL Single Dose Vial, packaged in 10-count x 10 mL Single Dose Vials per carton, Rx only, Mfd. By: Hikma Farmaceutica (Portugal), S.A.; Dist. By: West-Ward Pharmaceutical Corp., Eatontown, NJ 07724 USA under the labels a) NOVAPLUS (NDC 0143-9703-10), b) West-Ward (NDC 0143-9782-10). Package NDCs: 0143-9788-01; 0143-9788-25; 0143-9782-01; 0143-9782-10; 0143-9703-10 | Presence of Particulate Matter: This product is being recalled due to the discovery of particles in the stability samples and retain samples. | West-ward Pharmaceutical Corp. / a) 74,960 vials; b) 911,070 vials | Class II | Terminated |
| D-1382-2012 | 04-11-2012 | Propofol Injectable Emulsion, 1%, (10mg/mL), packaged in a) 200 mg/20 mL, 5 Units x 20 mL Single patient infusion vials per carton (NDC 0409-4699-30); b) 1 g/100 mL, 10 Units x 100 mL Single patient infusion vials per carton (NDC 0409-4699-24); Rx only, Hospira, Inc., Lake Forest, IL 60045, USA. Package NDCs: 0409-4699-50; 0409-4699-30; 0409-4699-53; 0409-4699-33; 0409-4699-54; 0409-4699-24; 0409-6010-02; 0409-6010-25 | Presence of Particulate Matter: A single visible particulate was observed in a retention sample bottles identified as stainless steel | Hospira, Inc. / a) 36,125 vials; b) 31,280 vials | Class II | Terminated |
| D-1371-2012 | 04-10-2012 | Carbon Dioxide, USP, Medical Gas, packaged in a) size EA aluminum, CGA940 (CDUSPEA), b) size E CGA 940 (CDUSPE), c) 50 lb CGA320 (CDUSP50, CD USP50S), d) size 160 liter (CD USP160LT350) cylinders, Rx only, Airgas, Puritan Medical, Distributed By: Airgas USA, LLC, Radnor, PA. | Impurities/Degradation Products: Out Of Specification levels of nitrogen dioxide. | Airgas Inc / 123 cylinders | Class II | Terminated |
| D-1435-2012 | 04-09-2012 | Dr. Reddy's Ciprofloxacin Tablets, USP 500 mg*, 500 Tablets, Rx only, Mfd. By: Dr. Reddy's Laboratories Limited, Bachepalli - 502 325 INDIA, NDC 55111-127-05 | Adulterated Presence of Foreign Tablets: Dr. Reddy's Laboratories has received complaints of mislabeled bottles of Amlodipine Besylate and Benazepril Hydrochloride Capsules and Ciprofloxacin Tablets | Dr. Reddy's Laboratories, Inc. / 1656 bottles | Class II | Terminated |
| D-1434-2012 | 04-09-2012 | Dr. Reddy's Amlodipine Besylate and Benazepril Hydrochloride 5 mg*/20 mg, 500 Capsules, Rx only, Mfd. By: Dr. Reddy's Laboratories Limited, Bachepalli - 502 325 INDIA, NDC 55111-340-05 Package NDCs: 55111-338-30; 55111-338-01; 55111-338-05; 55111-339-30; 55111-339-01; 55111-339-05; 55111-340-30; 55111-340-01; 55111-340-05; 55111-341-30; 55111-341-01; 55111-341-05 | Adulterated Presence of Foreign Tablets: Dr. Reddy's Laboratories has received complaints of mislabeled bottles of Amlodipine Besylate and Benazepril Hydrochloride Capsules and Ciprofloxacin Tablets. | Dr. Reddy's Laboratories, Inc. / 1656 bottles | Class II | Terminated |
| D-1390-2012 | 04-05-2012 | Magnesium Sulfate in Water for Injection, 40 mg/mL (0.325 mEq Mg++/mL), 2 g total, 50 mL Flexible Container, Rx only, Hospira, Inc., Lake Forest, IL 60045; NDC 0409-6729-24. Package NDCs: 0409-6730-11; 0409-6730-13; 0409-6730-50; 0409-6730-60; 0409-6729-41; 0409-6729-23; 0409-6729-21; 0409-6729-03; 0409-6729-31; 0409-6729-09; 0409-6729-11; 0409-6729-24; 0409-4121-01; 0409-4121-50; 0409-2050-01; 0409-2050-20; 0409-3164-01; 0409-3164-12; 0409-5239-01; 0409-5239-60 | Superpotent (Single Ingredient) Drug: Above specification assay results for percentage of magnesium sulfate. | Hospira, Inc. / 164,568 containers | Class III | Terminated |
| D-1443-2012 | 04-05-2012 | Meloxicam Tablets, USP, 15 mg, Rx Only, 100 Tablets per Bottle, Manufactured by: Strides Acrolab Ltd., Bangalore-560 076, India, Manufactured for: Apotex Corp., Weston, FL 33326, NDC 60505-3579-1. | Tablet Thickness: Recall was initiated due to the presence of one slightly oversized tablet in a bottle of the identified lot. | Apotex Corp. / 1,749 Bottles | Class II | Terminated |
| D-1396-2012 | 04-02-2012 | Mefloquine HCL Tablets, 250 mg, 5 tablets per blister pack; 5 Blister packs per carton, Rx only, Teva Pharmaceuticals USA Sellersville, PA 18960, Individual blister pack: NDC 0555-0171-88, 25 Unit-Dose Tablets (5x5) Carton: NDC 0555-0171-78 Package NDCs: 0555-0171-88; 0555-0171-78 | Tablet Thickness: Product is being recalled due to the potential of being underweight or overweight. | Teva Pharmaceuticals USA, Inc. / 4188 cartons (5 X 5 blisterpacks) | Class II | Terminated |
| D-001-2013 | 03-29-2012 | buPROPion Hydrochloride Extended-Release Tablets (XL), 150 mg, UD 100 Tablets (10 x 10) per carton, Rx only, Mfg By: CMIC-VPS Corporation, Cranbury, New Jersey 08512; blister barcode N (01)003 63739 449 10 7, Dist By: McKesson Packaging, Concord, NC 28027; NDC 63739-449-10, carton barcode 6373944910. | Failed USP Dissolution Test Requirements: Possible out-of-specification dissolution results at the 8 hour stability testing point. | McKesson Packaging Services / 187 cartons | Class III | Terminated |
| D-002-2013 | 03-29-2012 | buPROPion Hydrochloride Extended-Release Tablets (XL), 300 mg, UD 100 Tablets (10 x 10) per carton, Rx only, Mfg By: CMIC-VPS Corporation, Cranbury, New Jersey 08512; blister barcode N (01)003 63739 450 10 3, Dist By: McKesson Packaging, Concord, NC 28027; NDC 63739-450-10, carton barcode 6373945010. | Failed USP Dissolution Test Requirements: Possible out-of-specification dissolution results at the 8 hour stability testing point. | McKesson Packaging Services / 674 cartons | Class III | Terminated |
| D-1413-2012 | 03-22-2012 | Daytrana (Methylphenidate) Transdermal System Patch, Delivers 20 mg over 9 hours (2. 2 mg/hr), 1 patch per pouch (NDC 68968-5554-01) packaged in 3-count patches per box (NDC 68968-5554-3) , Rx only, Manufactured for Shire US Inc., Wayne, PA 19087 by Noven Pharmaceuticals, Inc., Miami, FL 33816.08/04/12. Package NDCs: 68968-5552-3; 68968-5553-3; 68968-5554-3; 68968-5555-3; 68968-5554-01 | Miscalibrated/Defective Delivery System; exceeded the specification for both mechanical peel force (MPF) and/or the z-statistic value | Noven Pharmaceuticals, Inc. / 185,160 patches | Class II | Terminated |
