Drug and pharmaceutical recalls
17728 federal recalls on file. Federal recalls for prescription drugs, OTC medications, supplements, and pharmaceuticals. Sourced from the FDA and translated into plain English.
- 2018-08-08FDA-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.
- 2018-08-01FDA-DrugTeva Pharmaceuticals USAClass IIValsartan and Hydrochlorothiazide (HCTZ) Tablets, USP 160 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 0591-2317-19.
CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product.
- 2018-08-01FDA-DrugTeva Pharmaceuticals USAClass IIValsartan and Hydrochlorothiazide (HCTZ) Tablets, USP 160 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 0591-2316-19.
CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product.
- 2018-08-01FDA-DrugTeva Pharmaceuticals USAClass IIValsartan and Hydrochlorothiazide (HCTZ) Tablets, USP 80 mg/12.5 mg tablets, 90 count-count bottle, Rx Only, Manufactured by: Arrow Pharma (Malta) Ltd. India, Distributed by: Actavis Pharma, Inc. Parsippany, NJ 07054, NDC 0591-2315-19.
CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product.
- 2018-08-01FDA-DrugMAJOR PHARMACEUTICALSClass IIIEnalapril Maleate Tablets, USP, 5 mg, 100 Tablets (10 x 10) Unit Dose per carton, Rx only, Manufactured by: Wockhardt Limited, H-14/2, M.I.D.C. Area, Waluj, Aurangabad, Maharashtra, India; Distributed by: Wockhardt USA LLC., 20 Waterview Blvd., Parsippany, NJ 07054; Distributed by: MAJOR Pharmaceuticals, 17177 N Laurel Park Dr., Suite 233, Livonia, MI 48152; NDC 0904-5502-61.
Failed Impurities/Degradation Specifications: Sub-recall because this repackaged product was recalled by the manufacturing firm, Wockhardt, due to out-of-specification results for the Enalapril DiKetopiperazine degradation product.
- 2018-08-01FDA-DrugMAJOR PHARMACEUTICALSClass IIIEnalapril Maleate Tablets, USP, 2.5 mg, 100 Tablets (10 x 10) Unit Dose per carton, Rx only, Manufactured by: Wockhardt Limited, H-14/2, M.I.D.C. Area, Waluj, Aurangabad, Maharashtra, India; Distributed by: Wockhardt USA LLC., 20 Waterview Blvd., Parsippany, NJ 07054; Distributed by: MAJOR Pharmaceuticals, 17177 N Laurel Park Dr., Suite 233, Livonia, MI 48152; NDC 0904-5609-61.
Failed Impurities/Degradation Specifications: Sub-recall because this repackaged product was recalled by the manufacturing firm, Wockhardt, due to out-of-specification results for the Enalapril DiKetopiperazine degradation product.
- 2018-08-01FDA-DrugSun Pharmaceutical Industries, Inc.Class IITestosterone Cypionate Injection, USP, 200 mg/mL, Rx only, 10 mL vials, Distributed by: Sun Pharmaceutical Industries, Inc., Cranbury, NJ 08512, Manufactured by: Sun Pharmaceutical Industries, Ltd., Halol-Baroda Highway, Halol-389 350, Gujarat, India, NDC 62756-016-40
Presence of Particulate Matter: organic and inorganic compounds detected in vials of product.
- 2018-08-01FDA-DrugPrinston Pharmaceutical IncClass IISolco Healthcare US Valsartan and Hydrochlorothiazide, USP, 320 MG/25 MG Tablets, 90-count bottles, Rx Only, Manufactured by: Zhejiang Huahai Pharmaceutical Co., Ltd. Xynqiao, Linhai, Zhejiang 317024, China Distributed by: Solco Healthcare US, LLC Cranbury, NJ 08512 USA NDC 43547-315-09
CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product.
- 2018-08-01FDA-DrugPrinston Pharmaceutical IncClass IISolco Healthcare US Valsartan and Hydrochlorothiazide, USP, 320 MG/12.5 MG Tablets, 90-count bottle, Rx Only, Manufactured by: Zhejiang Huahai Pharmaceutical Co., Ltd. Xynqiao, Linhai, Zhejiang 317024, China Distributed by: Solco Healthcare US, LLC Cranbury, NJ 08512 USA NDC 43547-314-09
CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product.
- 2018-08-01FDA-DrugPrinston Pharmaceutical IncClass IISolco Healthcare US Valsartan and Hydrochlorothiazide, USP, 160 MG/25 MG Tablets, 90-count bottle, Rx Only, Manufactured by: Zhejiang Huahai Pharmaceutical Co., Ltd. Xynqiao, Linhai, Zhejiang 317024, China Distributed by: Solco Healthcare US, LLC Cranbury, NJ 08512 USA NDC 43547-313-09
CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product.
- 2018-08-01FDA-DrugPrinston Pharmaceutical IncClass IISolco Healthcare US Valsartan and Hydrochlorothiazide, USP, 160 MG/12.5 MG Tablets, 90-count bottles, Rx Only, Manufactured by: Zhejiang Huahai Pharmaceutical Co., Ltd. Xynqiao, Linhai, Zhejiang 317024, China Distributed by: Solco Healthcare US, LLC Cranbury, NJ 08512 USA NDC 43547-312-09
CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product.
- 2018-08-01FDA-DrugPrinston Pharmaceutical IncClass IISolco Healthcare US Valsartan and Hydrochlorothiazide, USP, 80 MG/12.5 MG Tablets, 90-count bottles, Rx Only, Manufactured by: Zhejiang Huahai Pharmaceutical Co., Ltd. Xynqiao, Linhai, Zhejiang 317024, China Distributed by: Solco Healthcare US, LLC Cranbury, NJ 08512 USA NDC 43547-311-09
CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product.
- 2018-08-01FDA-DrugPrinston Pharmaceutical IncClass IISolco Healthcare US Valsartan, USP, 320 MG Tablets, 90-count bottle,Rx Only Manufactured by: Zhejiang Huahai Pharmaceutical Co., Ltd. Xynqiao, Linhai, Zhejiang 317024, China Distributed by: Solco Healthcare US, LLC Cranbury, NJ 08512 USA NDC 43547-370-09
CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product.
- 2018-08-01FDA-DrugPrinston Pharmaceutical IncClass IISolco Healthcare US Valsartan, USP, 160 MG Tablets, 90-count bottles, Rx Only Manufactured by: Zhejiang Huahai Pharmaceutical Co., Ltd. Xynqiao, Linhai, Zhejiang 317024, China Distributed by: Solco Healthcare US, LLC Cranbury, NJ 08512 USA NDC 43547-369-09
CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product.
- 2018-08-01FDA-DrugPrinston Pharmaceutical IncClass IISolco Healthcare US Valsartan, USP, 80 MG Tablets, 90-count bottle, Rx Only Manufactured by: Zhejiang Huahai Pharmaceutical Co., Ltd. Xynqiao, Linhai, Zhejiang 317024, China Distributed by: Solco Healthcare US, LLC Cranbury, NJ 08512 USA NDC 43547-368-09
CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product.
- 2018-08-01FDA-DrugPrinston Pharmaceutical IncClass IISolco Healthcare US Valsartan, USP, 40 MG Tablets, 30- count bottle, Rx Only, Manufactured by: Zhejiang Huahai Pharmaceutical Co., Ltd. Xynqiao, Linhai, Zhejiang 317024, China Distributed by: Solco Healthcare US, LLC Cranbury, NJ 08512 USA NDC 43547-367-03
CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product.
- 2018-08-01FDA-DrugMAJOR PHARMACEUTICALSClass IIUnit Dose Valsartan Tablets, USP. 160 mg. Rx only.,Distributed by: Major Pharmaceuticals, Livonia, MI 48152, NDC# 0904-6594-61. NDC# 0904-6595-61.
CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product.
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