RecallDepth
Class II Terminated

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.

Company
Bryant Ranch Prepack, Inc.
Recall Initiated
July 27, 2018
Posted
August 8, 2018
Recall Number
D-1028-2018
Voluntary / Mandated
Voluntary: Firm initiated
Quantity
990 tablets
Firm Location
Burbank, CA, United States

Reason for Recall

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

Distribution

Product was distributed in HI, IN, and FL.

Lot / Code Info

Lot # 114319; Exp. 10/18 Lot # 109004; Exp. 12/18

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