D-1134-2015 Class II Terminated
FDA drug recall D-1134-2015 was initiated by Allegiant Health on May 12, 2015 and is designated Class II. Reason for recall: CGMP Deviations: Failure of the manufacturer, Wockhardt Ltd, to adequately investigate customer complaints. The recall status is terminated (terminated Jun 5, 2018). Affected quantity: 86,106 Cartons.
Recall details
- Product Type
- Drugs
- Report Date
- Jun 24, 2015
- Initiation Date
- May 12, 2015
- Termination Date
- Jun 5, 2018
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 86,106 Cartons
Product description
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.
Distribution pattern
US Nationwide
Code information
Lot #: 3K34915, Expiry: 07/2015
Source
- Dataset
- openFDA drug recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for D-1134-2015
- openFDA file date
- Nov 10, 2026
- Loaded by RegDataLab
- Nov 11, 2026