Drug 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.
D-1044-2014
Product summary
- Event
- Event 66881
- Status
- Terminated
- Classification
- Class III
- Quantity
- 31,122 tubes
- Official record key
drug-enforcement:D-1044-2014
Official wording
Reason: Failed Impurities/Degradation Specifications: Out-of-Specification degradant results.
Code information: Lot #: 495P, Exp 07/14
Distribution pattern: Nationwide and Puerto Rico
Derived failure modes
-
Potency or specification failure
Out-of-Specification