Drug recall D-1029-2018

Class II Terminated reported Aug 8, 2018

Product

Valsartan 320 mg tablets, 90-count bottles ( NDC 71335-0567-2), Rx Only, Packaged by Bryant Ranch, Burbank, CA 91504.

Reason for recall

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

Lots and codes

Lot # 120879; Exp 10/19

Recall details

Recalling firm
Bryant Ranch Prepack Inc., Burbank, CA
Quantity
90 tablets
Distribution
Product was distributed in HI, IN, and FL.
Type
Voluntary: Firm initiated
Recall initiated
July 27, 2018
Terminated
April 22, 2021

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