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.
Recall initiated: 20131118
Status: Terminated
Classification: Class III
Recall type: Voluntary: Firm initiated