Valsartan and Hydrochlorothiazide (HCTZ) Tablets, USP 80 mg/12.5 mg tablets, 90 count-count bottle, Rx Only, Manufactured by: Arrow Pharma (Malta) Ltd. India, Distributed by: Actavis Pharma, Inc. Parsippany, NJ 07054, NDC 0591-2315-19.
CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product.
Product was distributed throughout the United States, including Hawaii and Puerto Rico
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0981-2018