Fougera Recalls Ketoconazole Cream Due to Out-of-Specification Degradants
Fougera Pharmaceuticals is recalling 31,122 tubes of Ketoconazole Cream 2% because of out-of-specification degradant results.
The agency’s classification
FDA (Drugs): Class III
Class III is a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 1/5 (Low).
Cosmetic or documentation issue. No expected health impact, but the manufacturer is correcting the affected products.
Our severity reasoning: The recall is classified as FDA 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
Fougera Pharmaceuticals Inc. is recalling 31,122 tubes of Ketoconazole Cream, 2%, 30 gram tube. The product is a prescription-only topical antifungal manufactured by E. Fougera & Co., a division of Fougera Pharmaceuticals Inc., located in Melville, New York. The specific lot affected is Lot #495P with an expiration date of 07/14. The product was distributed nationwide and in Puerto Rico.
The recall was initiated due to failed impurities and degradation specifications, specifically out-of-specification degradant results. This indicates that the chemical breakdown products in the medication exceeded the acceptable limits defined by the manufacturer's quality standards.
Consumers who have this specific lot of Ketoconazole Cream should stop using it and contact their healthcare provider or pharmacist for guidance. The recall is classified as Class III by the FDA, which indicates that the product is not likely to cause adverse health consequences.
The recalled product
- Product
- KETOCONAZOLE (KETOCONAZOLE)
- Brand
- KETOCONAZOLE
- Manufacturer
- Fougera Pharmaceuticals Inc.
- Category
- Drug — Topical Antifungal
- Hazard
- Affected units
- 31,122
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 #: 495P
- Exp 07/14
UPCs (2)
- 0301680099156
- 301680099309
Distribution
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