Allegiant Health Recalls Famotidine Tablets Due to Manufacturing Investigation Failures
Allegiant Health is recalling specific lots of over-the-counter famotidine tablets because the manufacturer failed to adequately investigate customer complaints.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II. The hazard is a CGMP deviation regarding complaint investigation, which is a quality control issue without reported illnesses or injuries, fitting the 'Moderate' criteria for low-risk or precautionary recalls.
Plain-English summary
Allegiant Health is recalling 86,106 cartons of Famotidine Tablets, USP, 20 mg, Over the Counter. The affected product was manufactured in India by Wockhardt Ltd and distributed under several brand names, including freds Acid Controller, HARMON FACE VALUES MAXIMUM STRENGTH Heartburn RELIEF, Health A2Z Maximum Strength HEARTBURN RELIEF, and MARKET BASKET Maximum Strength HEARTBURN RELIEF ACID CONTROL. The specific lot number is 3K34915, with an expiration date of 07/2015. The recall covers distribution across the US Nationwide.
The recall was initiated due to Current Good Manufacturing Practice (CGMP) deviations. Specifically, the manufacturer, Wockhardt Ltd, failed to adequately investigate customer complaints. This failure to investigate complaints represents a quality control issue rather than a confirmed safety hazard such as contamination or mislabeling.
Consumers who have purchased these specific cartons should check their lot numbers and expiration dates. If the product matches the recalled lot 3K34915, consumers should stop using it and return it to the place of purchase for a refund or contact the recalling firm for further instructions.
The recalled product
- 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
- Manufacturer
- Allegiant Health
- Category
- Drug — Over-the-Counter
- Affected units
- 86,106
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (2)
- Lot #: 3K34915
- Expiry: 07/2015
Distribution
Distributed nationwide across the United States.
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