Drug 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
D-241-2013
Product summary
- Event
- Event 62625
- Status
- Terminated
- Classification
- Class III
- Quantity
- 60,210 units
- Official record key
drug-enforcement:D-241-2013
Official wording
Reason: 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
Code information: Lot #: 835H, Exp 07/12
Distribution pattern: Nationwide
Derived failure modes
-
Potency or specification failure
Out Of Specification