Class III
Terminated
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
This recall has been terminated (originally issued April 10, 2013).
- Company
- Fougera Pharmaceuticals Inc.
- Recall Initiated
- July 18, 2012
- Posted
- April 10, 2013
- Recall Number
- D-241-2013
- Voluntary / Mandated
- Voluntary: Firm initiated
- Quantity
- 60,210 units
- Firm Location
- Melville, NY, United States
- Official Source
- View on FDA website ↗
Reason for Recall
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
Distribution
Nationwide
Lot / Code Info
Lot #: 835H, Exp 07/12
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