AvKARE Valsartan and Hydrochlorothiazide 320 mg/12.5 mg tablets, 90-count bottle, Rx Only, Manufactured for: AvKARE, Inc. Pulaski, TN 38478, NDC 42291-886-90

Recall Number: D-1176-2018

Firm: Avkare Incorporated

Classification: Class II

Status: Terminated

Report Date: 20180912

Initiation Date: 20180718

Termination Date: 20200507

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

AvKARE Valsartan and Hydrochlorothiazide 320 mg/12.5 mg tablets, 90-count bottle, Rx Only, Manufactured for: AvKARE, Inc. Pulaski, TN 38478, NDC 42291-886-90