Class II
Terminated
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.
This recall has been terminated (originally issued June 24, 2015).
- Company
- Allegiant Health
- Recall Initiated
- May 12, 2015
- Posted
- June 24, 2015
- Recall Number
- D-1134-2015
- Voluntary / Mandated
- Voluntary: Firm initiated
- Quantity
- 86,106 Cartons
- Firm Location
- Deer Park, NY, United States
- Official Source
- View on FDA website ↗
Reason for Recall
CGMP Deviations: Failure of the manufacturer, Wockhardt Ltd, to adequately investigate customer complaints.
Distribution
US Nationwide
Lot / Code Info
Lot #: 3K34915, Expiry: 07/2015
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