AVKARE Inc. recalls Valsartan Tablets, USP 80 mg Rx Only 50 Tablets (5x10) Unit Dose NDC 50268-784-15 Manufactured for: AvKARE, Inc. Pulaski
Recalled September 5, 2018 · FDA recall D-1131-2018 · AVKARE
Hazard
CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product. · FDA Class II
Units
728 cartons (36,400 tablets)
Sold at
U.S. Nationwide
Description
CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product.
Product
Valsartan Tablets, USP 80 mg Rx Only 50 Tablets (5x10) Unit Dose NDC 50268-784-15 Manufactured for: AvKARE, Inc. Pulaski, TN 38478
Manufacturer(s)
AVKARE Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →