FDA recalls, August 2012: 776 published

191 different companies appear this month.

Risk classification: Class I: 219 · Class II: 528 · Class III: 29

Same month, other agencies:CPSC 35 recallsNHTSA 66 recalls

Recalls this month

DateProduct
August 22, 2012THERACYS, (BCG VACCINE) LIVE W/DILUENT** 81MG INJECTABLE 1 VIAL 1 VIALS 12 VIAL …D-1624-2012Franck's Lab Inc., d.b.a. Franck's Compounding Lab
August 22, 201200-4309-028-01 - Trabecular Metal Reverse Shoulder Liner 40mm 65¿ Neck Angle Per surgica…Z-2213-2012Zimmer, Inc.
August 22, 2012HYALURONIDASE - PRESERVATIVE FREE 150 U/ML INJECTABLE 1 MLS, 10 MLS, 100 MLS, 12 MLS, 12.…D-1534-2012Franck's Lab Inc., d.b.a. Franck's Compounding Lab
August 22, 2012BACLOFEN/HYDROMORPHONE, P.F. 2000MCG/2.9MG/ML INTRATHECAL 20 ML; BACLOFEN/HYDROMORPHONE, …D-1461-2012Franck's Lab Inc., d.b.a. Franck's Compounding Lab
August 22, 2012BUPIVACAINE/LIDOCAINE/METHYLPREDNISOLONE 0.17% / 0.67% / 2.7% INJECTABLE 15 ML, 18.75 ML,…D-1477-2012Franck's Lab Inc., d.b.a. Franck's Compounding Lab
August 22, 2012ISOSULFAN BLUE 1% INJECTABLE 10 ML 15 ML (2 DIFFERENT PRODUCTS)D-1550-2012Franck's Lab Inc., d.b.a. Franck's Compounding Lab
August 22, 2012DMSO/HEPARIN/METHYLPREDNISOLONE 50%/5000U/40MG/50ML SOLUTION 300 MLS (1 PRODUCT)D-1507-2012Franck's Lab Inc., d.b.a. Franck's Compounding Lab
August 22, 2012FORSKOLIN/PAPAVARINE/PHENTOLAMINE 200MCG/40MG/3MG/ML INJECTABLE 5 ML; FORSKOLIN/PAPAVARIN…D-1523-2012Franck's Lab Inc., d.b.a. Franck's Compounding Lab
August 22, 2012PREDNISOLONE ACETATE 10MG/ML INJECTABLE 10 MLS (1 PRODUCT)D-1606-2012Franck's Lab Inc., d.b.a. Franck's Compounding Lab
August 22, 2012METHIONINE/INOSITOL/CHOLINE CHLORIDE/CHROM/B12 (C) 0.8/1.6/1.6/0.0001/0.03% INJE 10 ML …D-1572-2012Franck's Lab Inc., d.b.a. Franck's Compounding Lab
August 22, 2012ENGERIX-B, SDV** 20MCG/ML INJECTABLE 1 ML (1 PRODUCT)D-1513-2012Franck's Lab Inc., d.b.a. Franck's Compounding Lab
August 22, 2012LIDOCAINE HCL/EPINEPHRINE IN BSS - P.F., SULFITE-FREE 0.75%/0.025% INJECTABLE 24 ML …D-1560-2012Franck's Lab Inc., d.b.a. Franck's Compounding Lab
August 22, 2012METOCLOPRAMIDE HCL 5MG/ML (10MG/2ML) INJECTABLE 2 ML 20 ML 200 ML 394 M…D-1577-2012Franck's Lab Inc., d.b.a. Franck's Compounding Lab
August 22, 2012CYCLOPENTALATE/PHENYLEPHRINE 1%/2.5% OPHTHALMIC 5 ML (1 PRODUCT)D-1493-2012Franck's Lab Inc., d.b.a. Franck's Compounding Lab
August 22, 2012MEPIVACAINE HCL/EPINEPHRINE. 2%/1:100,000 (0.001%) INJECTABLE 30 ML 60 ML; MEPIVICA…D-1570-2012Franck's Lab Inc., d.b.a. Franck's Compounding Lab
August 22, 2012DEPO-TESTOSTERONE, MDV, 10ML** 200MG/ML INJECTABLE 10 ML (1 PRODUCT)D-1496-2012Franck's Lab Inc., d.b.a. Franck's Compounding Lab
August 22, 2012Shiley Reusable Cannula Low Pressure Cuffed Tracheostomy Tubes, model numbers (Worldwide)…Z-2174-2012Nellcor Puritan Bennett Inc. (dba Covidien LP)
August 22, 2012ATROPINE SULFATE 0.4MG/ML INJECTABLE 12 ML, 2 ML, 20 ML, 24 ML, 25 ML, 3 ML; ATROPINE/EP…D-1458-2012Franck's Lab Inc., d.b.a. Franck's Compounding Lab
August 22, 2012BRILLIANT BLUE G, P.F. 0.025% OPHTHALMIC 10 ML, 20 ML, 26 ML, 4 ML; BRILLIANT BLUE G, P…D-1468-2012Franck's Lab Inc., d.b.a. Franck's Compounding Lab
August 22, 2012PHENYLEPHRINE/TROPICAMIDE (P.F.) SOLUTION 2.5%/1% OPHTHALMIC 5 ML (1 PRODUCT)D-1600-2012Franck's Lab Inc., d.b.a. Franck's Compounding Lab
August 22, 2012KETOROLAC TROMETHAMINE 30MG/ML INJECTABLE 10 ML 24 ML 500 ML; KETOROLAC TRO…D-1552-2012Franck's Lab Inc., d.b.a. Franck's Compounding Lab
August 22, 2012BUPIVACAINE/CLONIDINE/MORPHINE/ZICONOTIDE, P.F. 20MG/400MCG/20MG/1.5MCG/ML INTRA 20 ML (1…D-1473-2012Franck's Lab Inc., d.b.a. Franck's Compounding Lab
August 22, 2012ACETIC ACID, IRRIGATION 3% SOLUTION 500 ML (1 PRODUCT)D-1448-2012Franck's Lab Inc., d.b.a. Franck's Compounding Lab
August 22, 2012THIOTEPA, LYOPHILIZED 15MG INJECTABLE 8 VIAL; THIOTEPA, LYOPHILIZED 30MG INJECTABLE 4…D-1626-2012Franck's Lab Inc., d.b.a. Franck's Compounding Lab
August 22, 2012AMIKACIN P. F. 250MG/ML INJECTABLE 2 ML,4 ML; AMIKACIN SULFATE**** 4ML SDV 250MG/ML INJE…D-1454-2012Franck's Lab Inc., d.b.a. Franck's Compounding Lab
August 22, 2012BeautyAngel Health Fitness Natural Collagen Stimulation Anti Aging For human use.Z-2183-2012JK Products & Services, Inc
August 22, 2012HEPARIN LOCK SODIUM*** (25X1ML) 100U/ML INJECTABLE 50 ML; HEPARIN LOCK SODIUM*** (25X5ML…D-1531-2012Franck's Lab Inc., d.b.a. Franck's Compounding Lab
August 22, 2012RIBOFLAVIN SOLUTION 0.1% OPHTHALMIC 10 ML 5 ML; RIBOFLAVIN SOLUTION, P.F. 0.1% OPHTHAL…D-1613-2012Franck's Lab Inc., d.b.a. Franck's Compounding Lab
August 22, 2012Edwards Lifesciences Swan-Ganz Thermodilution VIP Catheters Model 131F7J. For use in p…Z-2188-2012Edwards Lifesciences, LLC
August 22, 2012CYANOCOBALAMIN (VIT B12 ) 1,000MCG/ML INJECTABLE 1 ML, 10 ML, 100 ML, 12 ML, 120 ML, 15 M…D-1488-2012Franck's Lab Inc., d.b.a. Franck's Compounding Lab
August 22, 2012Topiramate Tablets, 50 mg, 30-count (3 x 10) unit-dose blisters per carton, Rx only, Mfd …D-1645-2012American Health Packaging
August 22, 2012FENTANYL, P.F. 100MCG/ML INJECTABLE 12 ML, 2 ML, 30 ML, 60 ML; FENTANYL, P.F. 50MCG/ML (…D-1518-2012Franck's Lab Inc., d.b.a. Franck's Compounding Lab
August 22, 2012BACTERIOSTATIC SODIUM CHLORIDE 10ML VIAL** 0.9% INJECTABLE 10 ML, 10 MLS, 100 ML, 120, 20…D-1463-2012Franck's Lab Inc., d.b.a. Franck's Compounding Lab
August 22, 2012Edwards Lifesciences Swan-Ganz Thermodilution VIP Catheters Model 151F7. For use in pa…Z-2196-2012Edwards Lifesciences, LLC
August 22, 2012DEXTROSE/PROCAINE HCL P.F. 12%/1% INJECTABLE 400 ML ( 1 PRODUCT)D-1500-2012Franck's Lab Inc., d.b.a. Franck's Compounding Lab
August 22, 2012SELENIUM 200MCG/ML INJECTABLE 150 ML 30 ML 60 ML (3 DIFFERENT PRODUCTS)D-1615-2012Franck's Lab Inc., d.b.a. Franck's Compounding Lab
August 22, 2012ESTRADIOL 25MG PELLETS 1 PELLET, 15 PEL, 15 PELLET, 2 PELLET, 2 TAB, 3 PELLET, 4 PELLET, …D-1515-2012Franck's Lab Inc., d.b.a. Franck's Compounding Lab
August 22, 2012FLUORESCEIN/INDOCYANINE, LYOPHILIZED 200MG/10MG VIAL INJECTABLE 12 VIAL, 20 VIAL, 24 VIAL…D-1519-2012Franck's Lab Inc., d.b.a. Franck's Compounding Lab
August 22, 2012TAUT, Cholangiogram Catheter Intraducer, Peritoneal Catheter, Teleflex Medical, Research …Z-2186-2012Teleflex Medical
August 22, 2012METHIONINE / INOSITOL / CHOLINE CHLORIDE 25MG/75MG/75MG/ML INJECTABLE 30 ML; METHIONI…D-1571-2012Franck's Lab Inc., d.b.a. Franck's Compounding Lab
August 22, 2012MITOMYCIN 1MG/ML SOLUTION 160 ML 40 ML 8…D-1581-2012Franck's Lab Inc., d.b.a. Franck's Compounding Lab
August 22, 2012POTASSIUM CHLORIDE ***(30ML VIAL) 2MEQ/ML INJECTABLE 750 MLS; POTASSIUM CHLORIDE IN NORM…D-1603-2012Franck's Lab Inc., d.b.a. Franck's Compounding Lab
August 22, 2012LIDOCAINE/SODIUM BICARBONATE/HEPARIN IRRIGATION 10.6MG/16.8MG/2667U/ML SOLUTIO 90 ML (…D-1562-2012Franck's Lab Inc., d.b.a. Franck's Compounding Lab
August 22, 2012OYSTER MEAT IQF TINY 40/8OZ PRODUCT OF KOREAF-1937-2012Icrest International LLC
August 22, 2012TOBRAMYCIN 1.4% (14MG/ML) OPHTHALMIC 15 ML 3 ML 7 ML; TOBRAMYCIN SOLUTION**…D-1627-2012Franck's Lab Inc., d.b.a. Franck's Compounding Lab
August 22, 2012DAPIPRAZOLE OPHTHALMIC 0.5% SOLUTION 10 ML; DAPIPRAZOLE, LYOPHILIZED, OPHTHALMIC KIT 0.5%…D-1495-2012Franck's Lab Inc., d.b.a. Franck's Compounding Lab
August 22, 2012HYDROMORPHONE P.F. 20MG/ML INTRATHECAL 40 ML; HYDROMORPHONE P.F. 25MG/ML INTRATHECAL 18 M…D-1540-2012Franck's Lab Inc., d.b.a. Franck's Compounding Lab
August 22, 2012BUPIVACAINE/CLONIDINE/MORPHINE, P.F. 20MG/400MCG/20MG/ML INTRATHECAL 20 ML (1 PRODUCT)D-1472-2012Franck's Lab Inc., d.b.a. Franck's Compounding Lab
August 22, 2012SESAME OPHTHALMIC OIL 60 ML (1 PRODUCT)D-1617-2012Franck's Lab Inc., d.b.a. Franck's Compounding Lab
August 22, 2012DOXORUBICIN HCL, LYOPHILIZED 10MG VIAL 2 VIAL; DOXORUBICIN HCL, LYOPHILIZED 50MG VIAL 1 V…D-1509-2012Franck's Lab Inc., d.b.a. Franck's Compounding Lab

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