# FDA recall D-1134-2015

> **Allegiant Health** · Class II · drug recall initiated 2015-05-12.

## 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.

## Distribution

US Nationwide

## Key facts

- **Recall number:** D-1134-2015
- **Recalling firm:** Allegiant Health
- **Classification:** Class II
- **Product type:** drug
- **Status:** Terminated
- **Initiation date:** 2015-05-12
- **Report date:** 2015-06-24
- **Termination date:** 2018-06-05

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Deer Park, NY, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1134-2015

## Citation

> AI Analytics. FDA recall D-1134-2015. Retrieved 2026-06-12 from https://api.ai-analytics.org/recall/D-1134-2015. Source: US FDA. Licensed CC0.

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