Teva Pharmaceuticals USA recalls Valsartan Tablets, USP 80 mg, 90-count bottle (NDC 0591-2168-19), 1000-count bottle (NDC 0591-2168-10), Rx Only, Rx Only
Recalled August 1, 2018 · FDA recall D-0987-2018 · Teva Pharmaceuticals USA
Hazard
CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product. · FDA Class II
Units
30,793 90-count bottles, 1,158 1000-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 80 mg, 90-count bottle (NDC 0591-2168-19), 1000-count bottle (NDC 0591-2168-10), 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 →