Famotodine Tablets recalled over manufacturing violations

Recall date

April 22, 2015

Source

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

Official notice title

Wockhardt Usa Inc. recalls Famotodine Tablets, USP, 20 mg Tablets, For Repacking Only, Packaged in 6500 Count Drums, Over the Counter. Manufacture…

Recall number

D-1266-2015

FDA classification

Class II

Brand / firm

Wockhardt Usa Inc.

Sold / distributed

U.S. Nationwide including Puerto Rico.

Why it was recalled

CGMP Deviations: Firm did not adequately investigate customer complaints.

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

What was recalled

Famotodine Tablets, USP, 20 mg Tablets, For Repacking Only, Packaged in 6500 Count Drums, Over the Counter. Manufactured by: Wockhardt Limited, Mumbai, India. Distributed by: Wockhardt USA LLC 20 Waterview Blvd. Parsippany, NJ 07054 USA. NDC: 64679-0374-09.