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FDA Recalls
›Drug Recalls

FDA Drug Recalls

Recalls of prescription drugs, over-the-counter medications, and compounded pharmaceuticals.

Classification

All Class I Class II Class III

Status

All Ongoing Completed Terminated

Date

All time Past 30 days Past 12 months

Showing 9121–9140 of 17,793 recalls

Class ITerminated

Dr. King's Natural Medicine Homeopathic Heavy Metal Detox, 2 fl. oz. (59 mL), King Bio, Inc., 3 Westside Dr. Asheville, NC 28806, UPC 357955228127, NDC 57955-2281-2

King Bio Inc.

Microbial contamination

July 20, 2018 · DrugView details →

Class ITerminated

Dr. King's Natural Medicine Homeopathic Climate Adaptation Cold & Damp, 2 fl. oz. (59 mL), King Bio, Inc., 3 Westside Dr. Asheville, NC 28806, UPC 357955528425, NDC 57955-0170-2

King Bio Inc.

Microbial contamination

July 20, 2018 · DrugView details →

Class ITerminated

Dr. King's SafeCare Rx Gout Symptom Relief, 2 fl. oz. (59 mL), King Bio, Inc., 3 Westside Drive, Asheville, NC 28806 USA, UPC 357955002123, NDC 57955-0021-2

King Bio Inc.

Microbial contamination

July 20, 2018 · DrugView details →

Class ITerminated

Dr. King's SafeCare Rx Smoke Control, 2 fl. oz. (59 mL), King Bio, Inc., 3 Westside Drive, Asheville, NC 28806 USA, UPC 357955303022, NDC 57955-3031-2

King Bio Inc.

Microbial contamination

July 20, 2018 · DrugView details →

Class ITerminated

Dr. King's SafeCare Rx CS-Lymph Hodgkins, 2 fl. oz. (59 mL), King Bio, Inc., 3 Westside Drive, Asheville, NC 28806 USA, UPC 357955021520, NDC 57955-0215-2

King Bio Inc.

Microbial contamination

July 20, 2018 · DrugView details →

Class ITerminated

Dr. King's SafeCare Rx LymePlex, 2 fl. oz. (59 mL), King Bio, Inc., 3 Westside Drive, Asheville, NC 28806 USA, UPC 357955006923, NDC 57955-0069-2

King Bio Inc.

Microbial contamination

July 20, 2018 · DrugView details →

Class IITerminated

Unit Dose Valsartan Tablets, USP, 80 mg. Rx only, Distributed by: Major Pharmaceuticals, Livonia, MI 48152, NDC# 0904-6594-61.

MAJOR PHARMACEUTICALS

CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product.

July 18, 2018 · DrugView details →

Class IITerminated

AvKARE Valsartan and Hydrochlorothiazide 320 mg/12.5 mg tablets, 90-count bottle, Rx Only, Manufactured for: AvKARE, Inc. Pulaski, TN 38478, NDC 42291-886-90

Avkare Incorporated

CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product.

July 18, 2018 · DrugView details →

Class IITerminated

Valsartan HCTZ, 160/12.5mg, 30 tablets per bottle, Rx Only, Repackaged By: Northwind Pharmaceuticals, Indianapolis, IN 46256. NDC: 51655-950-52

Northwind Pharmaceuticals LLC

CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product.

July 18, 2018 · DrugView details →

Class IITerminated

AvKARE Valsartan and Hydrochlorothiazide 160 mg/25 mg tablets, 90-count bottle, Rx Only, Manufactured for: AvKARE, Inc. Pulaski, TN 38478, NDC 42291-887-90

Avkare Incorporated

CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product.

July 18, 2018 · DrugView details →

Class IITerminated

Valsartan, 320mg, 30 tablets per bottle, Rx Only, Repackaged By: Northwind Pharmaceuticals, Indianapolis, IN 46256. NDC: 51655-0654-52

Northwind Pharmaceuticals LLC

CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product.

July 18, 2018 · DrugView details →

Class IITerminated

AvKARE Valsartan and Hydrochlorothiazide 160 mg/12.5 mg tablets, 90-count bottle, Rx Only, Manufactured for: AvKARE, Inc. Pulaski, TN 38478, NDC 42291-885-90

Avkare Incorporated

CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product.

July 18, 2018 · DrugView details →

Class IITerminated

Indomethacin 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.

Hetero Labs, Ltd. - Unit III

Failed Tablet/Capsule Specifications: customer complaints of deformed, clumped, misshaped, melted or stuck together capsules.

July 18, 2018 · DrugView details →

Class IITerminated

Valsartan, 80mg, 30 tablets per bottle, Rx Only, Repackaged By: Northwind Pharmaceuticals, Indianapolis, IN 46256. NDC: 51655-0652-52

Northwind Pharmaceuticals LLC

CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product.

July 18, 2018 · DrugView details →

Class IITerminated

Potassium 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.

VENSUN PHARMACEUTICALS INC

Failed Tablet/Capsule Specifications: Tablet breakage

July 18, 2018 · DrugView details →

Class IITerminated

AvKARE Valsartan and Hydrochlorothiazide 80 mg/12.5 mg tablets, 90-count bottle, Rx Only, Manufactured for: AvKARE, Inc. Pulaski, TN 38478, NDC 42291-884-90

Avkare Incorporated

CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product.

July 18, 2018 · DrugView details →

Class IITerminated

Valsartan, 160 mg, 30 tablets per bottle, Rx Only, Repackaged By: Northwind Pharmaceuticals, Indianapolis, IN 46256. NDC: 51655-460-52

Northwind Pharmaceuticals LLC

CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product.

July 18, 2018 · DrugView details →

Class IITerminated

AvKARE Valsartan and Hydrochlorothiazide 320 mg/25 mg tablets 90-count bottle, Rx Only, Manufactured for: AvKARE, Inc. Pulaski, TN 38478, NDC 42291-888-90

Avkare Incorporated

CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product.

July 18, 2018 · DrugView details →

Class IITerminated

Unit Dose Valsartan Tablets, USP. 160 mg. Rx only.,Distributed by: Major Pharmaceuticals, Livonia, MI 48152, NDC# 0904-6594-61. NDC# 0904-6595-61.

MAJOR PHARMACEUTICALS

CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product.

July 18, 2018 · DrugView details →

Class IITerminated

Potassium 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.

VENSUN PHARMACEUTICALS INC

Failed Tablet/Capsule Specifications: Tablet breakage

July 18, 2018 · DrugView details →

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