Drug and pharmaceutical recalls
17624 federal recalls on file. Federal recalls for prescription drugs, OTC medications, supplements, and pharmaceuticals. Sourced from the FDA and translated into plain English.
- 2018-08-15FDA-DrugNuCare Pharmaceuticals IncClass IIValsartan/HCTZ 160/12.5 mg Tablets, 90-count jar, Rx Only, Packaged by NuCare Pharmaceuticals, Inc., Orange, CA 92867, NDC 68071-4311-9
CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product.
- 2018-08-15FDA-DrugBaxter Healthcare CorporationClass IIILevofloxacin Injection in 5% Dextrose, 750 mg (5 mg/mL), 750 mg in 150 mL 5% Dextrose, 150 mL Single Use Container bag, Rx only, Manufactured for: Claris Lifesciences Inc., North Brunswick, NJ 08902; By: Claris Injectables Ltd., Gujarat, India, NDC 36000-048-24.
Superpotent Drug: High out of specification results for levofloxacin resulting in increased concentration of solution.
- 2018-08-15FDA-DrugBaxter Healthcare CorporationClass IIILevofloxacin Injection in 5% Dextrose, 500 mg (5 mg/mL), 500 mg in 100 mL 5% Dextrose, 100 mL Single Use Container bag, Rx only, Manufactured for: Claris Lifesciences Inc., North Brunswick, NJ 08902; By: Claris Injectables Ltd., Gujarat, India, NDC 36000-047-24.
Superpotent Drug: High out of specification results for levofloxacin resulting in increased concentration of solution.
- 2018-08-15FDA-DrugBaxter Healthcare CorporationClass IIILevofloxacin Injection in 5% Dextrose, 250 mg (5 mg/mL), 250 mg in 50 mL 5% Dextrose, 50 mL Single Use Container bag, Rx only, Manufactured for: Claris Lifesciences Inc., North Brunswick, NJ 08902; By: Claris Injectables Ltd., Gujarat, India, NDC 36000-046-24.
Superpotent Drug: High out of specification results for levofloxacin resulting in increased concentration of solution.
- 2018-08-08FDA-DrugLupin Pharmaceuticals Inc.Class IIIMoxifloxacin Ophthalmic Solution USP, 0.5%, 5 mL bottle, Rx only, Manufactured for: Lupin Pharmaceuticals Inc. Baltimore, Maryland 21202 United States, Manufactured by: Lupin Limited Pithampur (M.P.) 454 775, INDIA, NDC 68180-422-01
Failed Impurities/Degradation Specifications: An out-of-specification result in the related substance test during three month long-term stability study.
- 2018-08-08FDA-DrugRenaissance Lakewood, LLCClass IIIFluconazole Injection, USP, Iso-Osmotic Sodium Chloride Diluent, 200 mg in 100 mL (2 mg/mL), 100 mL Single Dose Flexible Container bag, Rx only, Manufactured for: Claris Lifesciences Inc., North Brunswick, NJ 08902; By: Claris Injectables Ltd., Gujarat, India, NDC a) 36000-002-10 and b) 36000-002-06.
Superpotent Drug: lots out of specification for elevated sodium chloride and fluconazole assay.
- 2018-08-08FDA-DrugRenaissance Lakewood, LLCClass IIIFluconazole Injection, USP, Iso-Osmotic Sodium Chloride Diluent, 200 mg in 100 mL (2 mg/mL), 100 mL Single Dose Flexible Container bag, Rx only, Manufactured for: Claris Lifesciences Inc., North Brunswick, NJ 08902; By: Claris Injectables Ltd., Gujarat, India, NDC 36000-002-10.
Failed Stability Specifications: lot out of specification for elevated water vapor.
- 2018-08-08FDA-DrugRenaissance Lakewood, LLCClass IIIFluconazole Injection, USP, Iso-Osmotic Sodium Chloride Diluent, 400 mg in 200 mL (2 mg/mL), 200 mL Single Dose Flexible Container bag, Rx only, Manufactured for: Claris Lifesciences Inc., North Brunswick, NJ 08902; By: Claris Injectables Ltd., Gujarat, India; NDC 36000-003-06.
Superpotent Drug and Failed Stability Specifications: lot out of specification for elevated sodium chloride and elevated water vapor.
- 2018-08-08FDA-DrugBryant Ranch Prepack Inc.Class IIValsartan 320 mg tablets, 90-count bottles ( NDC 71335-0567-2), Rx Only, Packaged by Bryant Ranch, Burbank, CA 91504.
CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product.
- 2018-08-08FDA-DrugBryant Ranch Prepack Inc.Class IIValsartan 320 mg tablets, 30-count bottles ( NDC 63629-6905-1), 90-count bottles (NDC 63629-6905-2), 28-count bottles (NDC 6362-96905-3), Rx Only, Packaged by Bryant Ranch, Burbank, CA 91504.
CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product.
- 2018-08-08FDA-DrugBryant Ranch Prepack Inc.Class IIValsartan 80 mg tablets, 90-count bottles (NDC 63629-6922-2), 60-count bottles ( 63629-6922-3), 28-count bottles (63629-6922-4), Rx Only, Packaged by Bryant Ranch, Burbank, CA 91504.
CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product.
- 2018-08-08FDA-DrugMAJOR PHARMACEUTICALSClass IIDoxycycline Hyclate Tablets, USP, 100 mg, Rx Only, 30 tablets, 3 x 10 unit dose Cartons, Mfd. by: West-Ward Pharmaceuticals Corp., Eatontown, NY 07724; Distributed by: Major Pharmaceuticals, 17177 N. Laurel Park Dr., Suite 233, Livonia, MI 48152 USA. NDC: 0904-0430-04
Failed Dissolution Specifications
- 2018-08-08FDA-DrugWest-Ward Columbus IncClass IIDoxycycline Hyclate Tablets, USP, 100 mg*. 500-count bottle, Rx only. Manufactured by: West-Ward Pharmaceuticals Corp. Eatontown, NJ 07724. NDC# 0143-2112-05.
Failed Dissolution Specifications:
- 2018-08-08FDA-DrugWest-Ward Columbus IncClass IIDoxycycline Hyclate Tablets, USP, 100 mg*. 50-count bottle, Rx only. Manufactured by: West-Ward Pharmaceuticals Corp. Eatontown, NJ 07724. NDC# 0143-2112-50.
Failed Dissolution Specifications:
- 2018-08-08FDA-DrugPFIZERClass IIDaptomycin for Injection, 500 mg per vial, packaged as 1 Single-dose vial per carton, Rx only, Hospira, Inc., Lake Forest, IL 60045 USA, NDC 0409-0106-01.
Microbial Contamination of Sterile Products: Product associated with reports of adverse events indicative of infusion reactions related to microbiological contamination.
- 2018-08-08FDA-DrugH J Harkins Company Inc dba Pharma PacClass IIValsartan tablets 160 mg, 90-count bottle, Rx Only, Repackaged by H.J. Harkins Co, Inc. Grover Beach, CA 93433, NDC 43547-0369-09. Tablet is yellow, capsule-shaped, biconvex, film-coated tablets debossed with 343 on one side and HH on the other side.
Carcinogen impurity detected in API used to manufacture drug product.
- 2018-08-08FDA-DrugRemedyRepack Inc.Class IIValsartan/HCTZ 320mg/12.5 mg tablet, 90-count bottle, Rx only, RemedyRepack, 625 Kolter Drive, Suite 4, Indiana, PA 15701
CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product.
- 2018-08-08FDA-DrugRemedyRepack Inc.Class IIValsartan/HCTZ 160 mg/12.5 mg tablet, 90-count bottle, Rx only, RemedyRepack, 625 Kolter Drive, Suite 4, Indiana, PA 15701
CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product.
- 2018-08-08FDA-DrugHetero Labs, Ltd. - Unit IIIClass IIIndomethacin Capsules, USP, 50 mg, 100-count bottles, Rx only, Manufactured for: Camber Pharmaceuticals, Inc., Piscataway, NJ 08854; By: Hetero, Hetero Labs Limited, Jeedimetla, Hyderabad - 500 055, India; NDC 31722-543-01.
Failed Tablet/Capsule Specifications: customer complaints of deformed, clumped, misshaped, melted or stuck together capsules.
- 2018-08-08FDA-DrugVENSUN PHARMACEUTICALS INCClass IIPotassium Citrate Extended-Release Tablets, USP, 10 mEq, 100-count bottles, Rx only, Manufactured for: Vensun Pharmaceuticals, Inc. Yardley, PA 19067, Manufactured by: Strides Shasun Limited, Puducherry - 605 014, India, NDC 42543-407-01.
Failed Tablet/Capsule Specifications: Tablet breakage
- 2018-08-08FDA-DrugVENSUN PHARMACEUTICALS INCClass IIPotassium Citrate Extended-Release Tablets, USP, 15 mEq, 100-count bottles, Rx only, Manufactured for: Vensun Pharmaceuticals, Inc. Yardley, PA 19067, Manufactured by: Strides Shasun Limited, Puducherry - 605 014, India, NDC 42543-408-01.
Failed Tablet/Capsule Specifications: Tablet breakage
- 2018-08-01FDA-DrugAidarex Pharmaceuticals LLCClass IIIEnalapril Maleate, USP 5MG, 30-count bottle, RX only. Packaged By: Aidarex Pharmaceuticals. Mfg: Wockhardt Ltd. India. NDC: 33261-0693-30
Out-of-specification results for the Enalapril Diketopiperazine degradation product during commercial stability.
- 2018-08-01FDA-DrugAidarex Pharmaceuticals LLCClass IIIEnalapril Maleate, USP 5MG, 90-count bottle, RX only. Packaged By: Aidarex Pharmaceuticals. Mfg: Wockhardt Ltd. India. NDC: 33261-0693-90
Out-of-specification results for the Enalapril Diketopiperazine degradation product during commercial stability.
- 2018-08-01FDA-DrugAidarex Pharmaceuticals LLCClass IIIEnalapril Maleate, USP 2.5MG, 90-count bottle, RX only. Packaged By: Aidarex Pharmaceuticals. Mfg: Wockhardt Ltd. India. NDC: 33261-0977-90
Out-of-specification results for the Enalapril Diketopiperazine degradation product during commercial stability.
- 2018-08-01FDA-DrugTeva Pharmaceuticals USAClass IIValsartan Tablets, USP 320 mg, 90-count bottle (NDC 0591-2170-19), 500-count bottle (NDC 0591-2170-05), Rx Only, Rx Only, Manufactured by: Arrow Pharma (Malta) Ltd. India, Distributed by: Actavis Pharma, Inc. Parsippany, NJ 07054.
CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product.
- 2018-08-01FDA-DrugTeva Pharmaceuticals USAClass IIValsartan Tablets, USP 160 mg, 90-count bottle (NDC 0591-2169-19), 1000-count bottle (NDC 0591-2169-10), Rx Only, Rx Only, Manufactured by: Arrow Pharma (Malta) Ltd. India, Distributed by: Actavis Pharma, Inc. Parsippany, NJ 07054
CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product.
- 2018-08-01FDA-DrugTeva Pharmaceuticals USAClass IIValsartan Tablets, USP 80 mg, 90-count bottle (NDC 0591-2168-19), 1000-count bottle (NDC 0591-2168-10), Rx Only, Rx Only, Manufactured by: Arrow Pharma (Malta) Ltd. India, Distributed by: Actavis Pharma, Inc. Parsippany, NJ 07054
CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product.
- 2018-08-01FDA-DrugTeva Pharmaceuticals USAClass IIValsartan Tablets, USP 40 mg, 30-count bottle (NDC 0591-2167-30), 90-count bottle (NDC 0591-2167-19), Rx Only, Rx Only, Manufactured by: Arrow Pharma (Malta) Ltd. India, Distributed by: Actavis Pharma, Inc. Parsippany, NJ 07054
CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product.
- 2018-08-01FDA-DrugTeva Pharmaceuticals USAClass IIValsartan and Hydrochlorothiazide (HCTZ) Tablets, USP 320 mg/25 mg tablets, USP, 90-count bottle, Rx Only, Rx Only, Manufactured by: Arrow Pharma (Malta) Ltd. India, Distributed by: Actavis Pharma, Inc. Parsippany, NJ 07054. NDC 0591-2318-19.
CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product.
- 2018-08-01FDA-DrugTeva Pharmaceuticals USAClass IIValsartan and Hydrochlorothiazide (HCTZ) Tablets, USP 320 mg/12.5 mg tablets, USP, 90-count bottle, Rx Only, Rx Only, Manufactured by: Arrow Pharma (Malta) Ltd. India, Distributed by: Actavis Pharma, Inc. Parsippany, NJ 07054. NDC 0591-2318-19
CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product.
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