Bryant Ranch Prepack Inc. recalls Valsartan 80 mg tablets, 90-count bottles (NDC 63629-6922-2), 60-count bottles ( 63629-6922-3), 28-count bottles (63629-
Recalled August 8, 2018 · FDA recall D-1027-2018 · Bryant Ranch Prepack
Hazard
CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product. · FDA Class II
Units
690 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 80 mg tablets, 90-count bottles (NDC 63629-6922-2), 60-count bottles ( 63629-6922-3), 28-count bottles (63629-6922-4), 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 →