Valsartan Tablets recalled over manufacturing violations

Recall date

August 14, 2018

Source

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

Official notice title

AVKARE Inc. recalls Valsartan Tablets, USP 80 mg Rx Only 50 Tablets (5x10) Unit Dose NDC 50268-784-15 Manufactured for: AvKARE, Inc. Pulask…

Recall number

D-1131-2018

FDA classification

Class II

Brand / firm

AVKARE Inc.

Sold / distributed

U.S. 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

Valsartan Tablets, USP 80 mg Rx Only 50 Tablets (5x10) Unit Dose NDC 50268-784-15 Manufactured for: AvKARE, Inc. Pulaski, TN 38478