Valsartan Tablets, USP 320 mg Rx Only 30 Tablets (6x5) Unit Dose NDC 50268-786-13 Manufactured for: AvKARE, Inc. Pulaski, TN 38478
Recall Number: D-1133-2018
Firm: AVKARE Inc.
Classification: Class II
Status: Terminated
Report Date: 20180905
Initiation Date: 20180814
Termination Date: 20200507
Reason for Recall
CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product.
Product Description
Valsartan Tablets, USP 320 mg Rx Only 30 Tablets (6x5) Unit Dose NDC 50268-786-13 Manufactured for: AvKARE, Inc. Pulaski, TN 38478