Valsartan Tablets, USP 40 mg Rx Only NDC 50268-783-15 50 Tablets (5x10) Unit Dose Manufactured for: AvKARE, Inc. Pulaski, TN 38478
Recall Number: D-1130-2018
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 40 mg Rx Only NDC 50268-783-15 50 Tablets (5x10) Unit Dose Manufactured for: AvKARE, Inc. Pulaski, TN 38478