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.

Recall Number: D-1027-2018

Firm: Bryant Ranch Prepack Inc.

Classification: Class II

Status: Terminated

Report Date: 20180808

Initiation Date: 20180727

Termination Date: 20210422

CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug 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.