US Drug Recall Register
Class II · Moderate risk Terminated Initiated Apr 22, 2015 (11 years ago)

Famotodine Tablets

Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.

Why it was recalled

CGMP Deviations: Firm did not adequately investigate customer complaints.

What was recalled

Famotodine Tablets, USP, 10 mg Tablets, For Repacking Only, Packaged in 50,000 Count Drums, Over the Counter. Manufactured by: Wockhardt Limited, Mumbai, India. Distributed by: Wockhardt USA LLC 20 Waterview Blvd. Parsippany, NJ 07054 USA. NDC: 64679-0972-00.

Recalling firm
Wockhardt Usa Inc.
Origin
NJ, United States
Initiated by
Voluntary: Firm initiated
FDA recall number
D-1267-2015

What should you do? A recall doesn't always mean your specific bottle is affected - it often applies to certain lots only. Check the lot number on your package against the FDA notice, and talk to your pharmacist before stopping any medication.