Teva Pharmaceuticals USA recalls Valsartan Tablets, USP 320 mg, 90-count bottle (NDC 0591-2170-19), 500-count bottle (NDC 0591-2170-05), Rx Only, Rx Only
Recalled August 1, 2018 · FDA recall D-0989-2018 · Teva Pharmaceuticals USA
Hazard
CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product. · FDA Class II
Units
13,555 90-count bottles; 2,892 500-count bottles
Sold at
Product was distributed throughout the United States, including Hawaii and Puerto Rico
Description
CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product.
Product
Valsartan Tablets, USP 320 mg, 90-count bottle (NDC 0591-2170-19), 500-count bottle (NDC 0591-2170-05), Rx Only, Rx Only, Manufactured by: Arrow Pharma (Malta) Ltd. India, Distributed by: Actavis Pharma, Inc. Parsippany, NJ 07054.
Manufacturer(s)
Teva Pharmaceuticals USA
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →