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.
Recall Number: D-1044-2014
Firm: Fougera Pharmaceuticals Inc.
Classification: Class III
Status: Terminated
Report Date: 20140205
Initiation Date: 20131118
Termination Date: 20160509
Reason for Recall
Failed Impurities/Degradation Specifications: Out-of-Specification degradant results.
Product Description
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.