FDAFDA · Food and drugs·Recall number D-241-2013
Fougera Ketoconazole Cream 2%, 15g tube, Rx only, Labeled with E. Fougera & Co., a division of Fougera Pharmaceuticals Inc., Melville, New York 11747, NDC 0168-0099-15
Published April 10, 2013 · Recall initiated: July 18, 2012
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Failed Impurities/Degradation Specifications: Ketoconazole Cream 2% is the subject of a voluntary drug recall by Fougera due to an Out Of Specification result for an unknown degradant product
What to do
Voluntary: Firm initiated · Letter
Recall details
- Brand
- KETOCONAZOLE
- Manufacturer
- Fougera Pharmaceuticals Inc.
- Distributor
- Nationwide
- UPC
- 0301680099156
- Lot
- Lot #: 835H, Exp 07/12
- Risk classification
- Class III
- Area (FDA)
- drug
- Country
- United States
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