Famotidine tablets recalled for inadequate complaint investigation
American Health Packaging is recalling 97,837 cartons of Famotidine tablets 20mg due to CGMP deviations involving inadequate investigation of 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 due to CGMP deviations (inadequate complaint investigation) without reported injuries or illnesses, fitting the criteria for moderate severity involving procedural or low-risk issues.
Plain-English summary
American Health Packaging is recalling 97,837 cartons of Famotidine tablets, USP 20mg, packaged in 10-count blisters. The product is distributed nationwide and is available by prescription only. The recall involves specific lots with expiration dates ranging from June 30, 2015, to January 31, 2016.
The recall was initiated due to Current Good Manufacturing Practice (CGMP) deviations. Specifically, the firm did not adequately investigate customer complaints. The agency has classified this recall as Class II.
Consumers with this product should contact their healthcare provider or pharmacist for guidance on how to dispose of the medication or obtain a replacement. The recall number is D-1225-2015.
The recalled product
- Product
- Famotidine tablets, USP 20mg, packaged in 10-count blisters (NDC 68084-172-11); 10 blister packs per carton (NDC 68084-172-01); Rx only, Manufactured by: Wockhardt Limited, Mumbai, India, Distributed by: Wockhardt, USA, LLC 20 Waterview Blvd. Parsippany, NJ 07054 USA for America
- Manufacturer
- American Health Packaging
- Category
- Drug — Prescription Medication
- Affected units
- 97,837
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 (11)
- Lot#: 132146
- Exp 06/30/2015
- Lot#: 132147
- 132963
- Exp 08/31/2015
- Lot#: 132964
- Exp 10/31/2015
- Lot#: 134319
- Exp 12/31/2015
- Lot#: 134320
- Exp 01/31/2016.
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 13 recalled by American Health Packaging under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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