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.

Recall Number: D-1028-2018

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 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.