US Drug Recall Register
Class II · Moderate risk Terminated Initiated May 12, 2015 (11 years ago)

Famotidine Tablets, USP, 20 mg Tablets, Over the Counter, Made in India and labeled: a)…

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

Why it was recalled

CGMP Deviations: Failure of the manufacturer, Wockhardt Ltd, to adequately investigate customer complaints.

What was recalled

Famotidine Tablets, USP, 20 mg Tablets, Over the Counter, Made in India and labeled: a) freds Acid Controller, 25 Tablet Cartons, DISTRIBUTED BY: fred's, Inc. 4300 NEW GETWELL RD, MEMPHIS, TN 38118. UPC: 0 84579 12592 0. b) HARMON FACE VALUES MAXIMUM STRENGTH Heartburn RELIEF, 25 Tablet Cartons, Distributed by Harmon Stores, Inc. 650 Liberty Ave. Union, NJ 07083, UPC: 3 62211 93292 2. c) Health A2Z Maximum Strength HEARTBURN RELIEF, 8 Tablet Cartons, Manufactured for: A&Z Pharmaceutical Inc. Hauppauge, NY 11788. UPC: 3 62211 34929 4. d) MARKET BASKET Maximum Strength HEARTBURN RELIEF ACID CONTROL, 30 Tablet Cartons, Distributed by: Demoulas Supermarkets, Inc. 875 East St. Tewksbury, MA 01876, UPC: 0 49705 83147 2.

Recalling firm
Allegiant Health
Origin
NY, United States
Initiated by
Voluntary: Firm initiated
FDA recall number
D-1134-2015

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.

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