Valsartan 320 mg tablets, 90-count bottles ( NDC 71335-0567-2), Rx Only, Packaged by Bryant Ranch, Burbank, CA 91504.
Recall Number: D-1029-2018
Firm: Bryant Ranch Prepack Inc.
Classification: Class II
Status: Terminated
Report Date: 20180808
Initiation Date: 20180727
Termination Date: 20210422
Reason for Recall
CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product.
Product Description
Valsartan 320 mg tablets, 90-count bottles ( NDC 71335-0567-2), Rx Only, Packaged by Bryant Ranch, Burbank, CA 91504.