Drug recall D-1134-2015

Class II Terminated reported Jun 24, 2015

Product

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.

Reason for recall

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

Lots and codes

Lot #: 3K34915, Expiry: 07/2015

Recall details

Recalling firm
Allegiant Health, Deer Park, NY
Quantity
86,106 Cartons
Distribution
US Nationwide
Type
Voluntary: Firm initiated
Recall initiated
May 12, 2015
Terminated
June 5, 2018