Avkare Incorporated recalls AvKARE Valsartan and Hydrochlorothiazide 320 mg/25 mg tablets 90-count bottle, Rx Only, Manufactured for: AvKARE, Inc. P
Recalled September 12, 2018 · FDA recall D-1177-2018 · Avkare Incorporated
Hazard
CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product. · FDA Class II
Units
19623 bottles
Sold at
Nationwide
Description
CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product.
Product
AvKARE Valsartan and Hydrochlorothiazide 320 mg/25 mg tablets 90-count bottle, Rx Only, Manufactured for: AvKARE, Inc. Pulaski, TN 38478, NDC 42291-888-90
Manufacturer(s)
Avkare Incorporated
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →