AVKARE Inc. recalls Valsartan Tablets, USP 320 mg Rx Only 30 Tablets (6x5) Unit Dose NDC 50268-786-13 Manufactured for: AvKARE, Inc. Pulaski
Recalled September 5, 2018 · FDA recall D-1133-2018 · AVKARE
Hazard
CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product. · FDA Class II
Units
1496 cartons (44,880 tablets)
Sold at
U.S. Nationwide
Description
CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product.
Product
Valsartan Tablets, USP 320 mg Rx Only 30 Tablets (6x5) Unit Dose NDC 50268-786-13 Manufactured for: AvKARE, Inc. Pulaski, TN 38478
Manufacturer(s)
AVKARE Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →