Lupin Recalls Famotidine Oral Suspension Due to Manufacturing Deviations
Lupin Pharmaceuticals is recalling 12,888 bottles of Famotidine for Oral Suspension due to CGMP deviations. The FDA classified this voluntary recall as Class III.
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 recall as Class III, which the rubric defines as typically resulting in a score of 1 or 2 because it is unlikely to cause adverse health consequences.
Plain-English summary
Lupin Pharmaceuticals Inc. is voluntarily recalling 12,888 bottles of Famotidine for Oral Suspension USP, 40 mg/5 mL, 50 mL bottles. The product is prescription-only and was distributed nationwide in the USA. The specific lot affected is G606950 with an expiration date of 07/18.
The recall was initiated because of Current Good Manufacturing Practice (CGMP) deviations. The FDA has classified this recall as Class III, which indicates that use of or exposure to the violative product is not likely to cause adverse health consequences. The recall was initiated on May 2, 2017, and was terminated on March 28, 2018.
Consumers and healthcare providers should check their inventory for the specific lot number G606950. If the product is found, it should be returned to the pharmacy or supplier for disposal or credit, as directed by the recalling firm.
The recalled product
- Product
- FAMOTIDINE (FAMOTIDINE)
- Brand
- FAMOTIDINE
- Manufacturer
- Lupin Pharmaceuticals Inc.
- Category
- Drug — Prescription Drug
- Hazard
- Affected units
- 12,888
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 #: G606950
- Exp 07/18
UPCs (1)
- 0368180150015
Distribution
Distributed nationwide across the United States.
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