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.
- 2018-08-01FDA-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.
- 2018-08-01FDA-DrugMAJOR PHARMACEUTICALSClass IIUnit Dose Valsartan Tablets, USP, 80 mg. Rx only, Distributed by: Major Pharmaceuticals, Livonia, MI 48152, NDC# 0904-6594-61.
CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product.
- 2018-07-25FDA-DrugAvella of Deer Valley, Inc. Store 38Class IIPHENYLephrine 10 mg (PHENYLephrine HCL (USP) 10mg, 0.9% Sodium Chloride (USP) 250 mL. Volume: 251 mL Single dose bag. For: Redlands Community Hospital Pharmacy. BY: Advanced Pharma, 9265 Kirby Dr., Houston, TX 77054 NDC 15082-856-25
Lack of Assurance of Sterility: Potential leakage of bags.
- 2018-07-25FDA-DrugAvella of Deer Valley, Inc. Store 38Class IIePHEDrine Sulfate, USP 50 mg in 0.9% Sodium Chloride, USP QS 10mL. 50 mg/10 mL (5 mg per mL). Volume 10 mL Single dose syringe. Avella of Houston, 9265 Kirby Dr., Houston, TX 77054 NDC 42852-895-61
Lack of Assurance of Sterility: Potential leakage of bags.
- 2018-07-25FDA-DrugAvella of Deer Valley, Inc. Store 38Class IIePHEDrine Sulfate, USP 25 mg in 0.9% Sodium Chloride, USP QS 5mL. Volume 5 mL Single dose syringe. Avella of Houston, 9265 Kirby Dr., Houston, TX 77054 NDC 42852-805-67
Lack of Assurance of Sterility: Potential leakage of bags.
- 2018-07-25FDA-DrugAvella of Deer Valley, Inc. Store 38Class IIPHENYLephrine 20 mg (PHENYLephrine HCL (USP) 20 mg, 5% Dextrose (USP) 250 mL) Volume: 252 mL. Single dose bag. For: Vidant Medical Center, By: Avella of Houston, 9265 Kirby Dr., Houston, TX 77054. NDC 42852-894-25
Lack of Assurance of Sterility: Potential leakage of bags.
- 2018-07-25FDA-DrugAvella of Deer Valley, Inc. Store 38Class IINORepiNEPHrine4mg (Norepinephrine Bitartrate (USP) 4 mg added to 0.9% Sodium Chloride (USP) 250 mL Volume: 254 mL Single dose bag. Avella of Houston, 9265 Kirby Dr. Houston, TX 77054. NDC 42852-860-25
Lack of Assurance of Sterility: Potential leakage of bags.
- 2018-07-25FDA-DrugAvella of Deer Valley, Inc. Store 38Class IINORepiNEPHrine4mg (Norepinephrine Bitartrate (USP) 4 mg added to 5% Dextrose Inj. (USP) 250 mL (Concentration 16 mcg/mL) Volume: 254 mL Single dose bag. Avella of Houston, 9265 Kirby Dr. Houston, TX 77054. NDC 42852-807-25
Lack of Assurance of Sterility: Potential leakage of bags.
- 2018-07-25FDA-DrugAvella of Deer Valley, Inc. Store 38Class IINORepiNEPHrine Bitartrate, USP 160 mcg in 5% Dextrose, USP QS 10mL. Volume 10mL. Single dose syringe. Avella of Houston, 9265 Kirby Dr. Houston, TX 77054. NDC 42852-807-61
Lack of Assurance of Sterility: Potential leakage of bags.
- 2018-07-25FDA-DrugAvella of Deer Valley, Inc. Store 38Class IINORepiNEPHrine 16 (NORepiNEPHrine Bitartrate (USP) 16 mg, 5% Dextrose Inj. (USP) 250 mL. Volume: 266 mL. Single dose bag. Avella of Houston, 9265 Kirby Dr. Houston, TX 77054. NDC 42852-834-25
Lack of Assurance of Sterility: Potential leakage of bags.
- 2018-07-25FDA-DrugAvella of Deer Valley, Inc. Store 38Class IIMidazolam 1 mg/mL (Midazolam HCL (USP) 55 mg, 0.9% Sodium Chloride, (USP) QS 55 mL) Volume: 55mL. Single dose syringe. Advanced Pharma, 9265 Kirby Dr., Houston TX 77054. NDC 15082-401-76
Lack of Assurance of Sterility: Potential leakage of bags.
- 2018-07-25FDA-DrugAvella of Deer Valley, Inc. Store 38Class IIMidazolam 0.5mg/mL (Midazolam HCL (USP) 50 mg, 0.9% Sodium Chloride, USP QS 100 mL) Volume: 100 mL. Single dose bag. For: Coral Gables Hospital, By: Advanced Pharma, 9265 Kirby Dr., Houston TX 77054. NDC 15082-408-10
Lack of Assurance of Sterility: Potential leakage of bags.
- 2018-07-25FDA-DrugAvella of Deer Valley, Inc. Store 38Class IIMidazolam 1 mg/mL (Midazolam HCL USP 30 mg, 0.9% Sodium Chloride, USP QS 30 mL) Volume: 30 mL. Single dose syringe. For: Methodist Willowbrook Hospital, By: Advanced Pharma, 9265 Kirby Dr., Houston TX 77054. NDC 15082-401-63
Lack of Assurance of Sterility: Potential leakage of bags.
- 2018-07-25FDA-DrugAvella of Deer Valley, Inc. Store 38Class IIMORphine 150 mg (Morphine Sulfate, USP 150mg in 0.9% Sodium Chloride, USP QS 30mL). Volume 30 mL. Single dose syringe. Avella of Houston, 9265 Kirby Dr., Houston, TX 77054. NDC 42852-243-63
Lack of Assurance of Sterility: Potential leakage of bags.
- 2018-07-25FDA-DrugAvella of Deer Valley, Inc. Store 38Class IIMORphine 1 mg/mL (Morphine Sulfate, USP 250mg, 0.9% Sodium Chloride, USP 250 mL). Volume 255 mL. Single dose bag. Avella of Houston, 9265 Kirby Dr., Houston, TX 77054. NDC 42852-241-25
Lack of Assurance of Sterility: Potential leakage of bags.
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