Mylan Recalls Famotidine Tablets Due to Out-of-Specification Impurities
Mylan Pharmaceuticals is recalling 31,867 bottles of Famotidine Tablets USP, 20 mg, due to out-of-specification results for related compounds found during routine stability testing.
What this means for you
Cosmetic or documentation issue. No expected health impact, but the manufacturer is correcting the affected products.
Our severity reasoning: The FDA classified this as a Class III recall, which by definition is unlikely to cause adverse health consequences, aligning with the 'Low' severity criteria for documentation or minor specification issues.
Plain-English summary
Mylan Pharmaceuticals Inc. is voluntarily recalling 31,867 bottles of Famotidine Tablets USP, 20 mg (NDC 0378-3020-01). The recall is being conducted because routine stability testing revealed out-of-specification results for related compounds, which are impurities or degradation products.
The affected product is Lot 3018952 with an expiration date of 08/12. The recall covers distribution nationwide and in Puerto Rico. The FDA has classified this recall as Class III, indicating that use of or exposure to the violative product is not likely to cause adverse health consequences.
Consumers and healthcare providers should stop using the affected lot of Famotidine Tablets and return them to the pharmacy or point of purchase for a refund or replacement. Patients should consult their healthcare provider for alternative treatment options if necessary.
The recalled product
- Product
- Famotidine Tablets USP, 20 mg, 100 count bottles, Rx Only, Mylan Pharmaceuticals, Inc., Morgantown, WV 26505 U.S.A. NDC 0378-3020-01
- Manufacturer
- Mylan Pharmaceuticals Inc.
- Category
- Drug — Prescription Medication
- Affected units
- 31,867
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: 3018952
- Exp 08/12
Distribution
Distributed nationwide across the United States.
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