Drug recall D-241-2013
Product
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
Reason for recall
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
Lots and codes
Lot #: 835H, Exp 07/12
Recall details
- Recalling firm
- Fougera Pharmaceuticals Inc., Melville, NY
- Quantity
- 60,210 units
- Distribution
- Nationwide
- Type
- Voluntary: Firm initiated
- Recall initiated
- July 18, 2012
- Terminated
- December 10, 2015
Related products
- Ketoconazole – drug information
- NDC 0168-0099 Ketoconazole · Ketoconazole 20 mg/g · E. Fougera & Co. a division of Fougera Pharmaceuticals, LLC