AvKARE Valsartan and Hydrochlorothiazide 80 mg/12 recalled over manufacturing violations

Recall date

July 18, 2018

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Official notice title

Avkare Incorporated recalls AvKARE Valsartan and Hydrochlorothiazide 80 mg/12.5 mg tablets, 90-count bottle, Rx Only, Manufactured for: AvKARE, Inc…

Recall number

D-1173-2018

FDA classification

Class II

Brand / firm

Avkare Incorporated

Sold / distributed

Nationwide

Why it was recalled

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

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

AvKARE Valsartan and Hydrochlorothiazide 80 mg/12.5 mg tablets, 90-count bottle, Rx Only, Manufactured for: AvKARE, Inc. Pulaski, TN 38478, NDC 42291-884-90