Fougera Recalls Ketoconazole Cream 2% Due to Unknown Degradant
Fougera Pharmaceuticals is voluntarily recalling 60,210 units of Ketoconazole Cream 2% because an unknown degradant failed impurity specifications.
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 recall is classified as FDA Class III, which by definition is unlikely to cause adverse health consequences, aligning with the 'Low' severity criteria for documentation or minor specification issues without reported harm.
Plain-English summary
Fougera Pharmaceuticals Inc. is voluntarily recalling 60,210 units of Ketoconazole Cream 2%, 15g tubes, due to an Out Of Specification result for an unknown degradant product. The affected product is labeled with E. Fougera & Co., a division of Fougera Pharmaceuticals Inc., and carries NDC 0168-0099-15. The specific lot number is 835H with an expiration date of 07/12.
The recall is classified as Class III by the FDA, indicating that use of or exposure to the violative product is not likely to cause adverse health consequences. The distribution pattern for the recalled units is nationwide. The product is a prescription-only topical antifungal medication.
Consumers and healthcare providers should check their inventory for the specific lot number and expiration date listed above. If the product matches the recalled description, it should be returned to the pharmacy or point of purchase for disposal or credit. No specific instructions for consumer action beyond standard recall procedures are provided in the source text.
The recalled product
- Product
- KETOCONAZOLE (KETOCONAZOLE)
- Brand
- KETOCONAZOLE
- Manufacturer
- Fougera Pharmaceuticals Inc.
- Category
- Drug — Topical Antifungal
- Hazard
- Affected units
- 60,210
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 #: 835H
- Exp 07/12
UPCs (1)
- 0301680099156
Distribution
Distributed nationwide across the United States.
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