Product: Valsartan and Hydrochlorothiazide (HCTZ) Tablets, USP 160 mg/12.5 mg tablets, USP 90-count bottle, Rx Only, Rx Only, Manufactured by: Arrow Pharma (Malta) Ltd. India, Distributed by: Actavis Pharma, Inc. Parsippany, NJ 07054. NDC 0591-2316-19.
Reason for recall: CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product.
Recall initiated: 20180716
Status: Ongoing
Classification: Class II
Recall type: Voluntary: Firm initiated