Product: Valsartan Tablets, USP 160 mg Rx Only 50 Tablets (5x10) Unit Dose NDC 50268-785-15 Manufactured for: AvKARE, Inc. Pulaski, TN 38478
Reason for recall: CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product.
Recall initiated: 20180814
Status: Terminated
Classification: Class II
Recall type: Voluntary: Firm initiated