Drug recall D-1044-2014
Product
KETOCONAZOLE CREAM, 2%, 30 gram tube, Rx only, E. FOUGERA & CO., A division of Fougera Pharmaceuticals Inc., Melville, New York 11747, NDC 0168-0099-30, UPC 3 0168-0099-30 9.
Reason for recall
Failed Impurities/Degradation Specifications: Out-of-Specification degradant results.
Lots and codes
Lot #: 495P, Exp 07/14
Recall details
- Recalling firm
- Fougera Pharmaceuticals Inc., Melville, NY
- Quantity
- 31,122 tubes
- Distribution
- Nationwide and Puerto Rico
- Type
- Voluntary: Firm initiated
- Recall initiated
- November 18, 2013
- Terminated
- May 9, 2016
Related products
- Ketoconazole – drug information
- NDC 0168-0099 Ketoconazole · Ketoconazole 20 mg/g · E. Fougera & Co. a division of Fougera Pharmaceuticals, LLC