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. Hau
Reason for recall: CGMP Deviations: Failure of the manufacturer, Wockhardt Ltd, to adequately investigate customer complaints.
Recall initiated: 20150512
Status: Terminated
Classification: Class II
Recall type: Voluntary: Firm initiated