Bryant Ranch Prepack Inc. recalls Valsartan 320 mg tablets, 30-count bottles ( NDC 63629-6905-1), 90-count bottles (NDC 63629-6905-2), 28-count bottles (N
Recalled August 8, 2018 · FDA recall D-1028-2018 · Bryant Ranch Prepack
Hazard
CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product. · FDA Class II
Units
990 tablets
Sold at
Product was distributed in HI, IN, and FL.
Description
CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product.
Product
Valsartan 320 mg tablets, 30-count bottles ( NDC 63629-6905-1), 90-count bottles (NDC 63629-6905-2), 28-count bottles (NDC 6362-96905-3), Rx Only, Packaged by Bryant Ranch, Burbank, CA 91504.
Manufacturer(s)
Bryant Ranch Prepack Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →