Status
Terminated
Drug Enforcement D-241-2013
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
Classification
Class III
Report Date
April 10, 2013
Termination Date
December 10, 2015
Product Information
- Product description
- 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
- Product quantity
- 60,210 units
- 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
- Recall initiation reason
- —
- Initial firm notification
- Letter
- Distribution pattern
- Nationwide
Location & Firm
- Recalling firm
- Fougera Pharmaceuticals Inc.
- Address
-
60 Baylis Road, N/A
United States - Voluntary / Mandated
- Voluntary: Firm initiated
- Status date
- —
Codes & Dates
- Recall number
- D-241-2013
- Event ID
- 62625
- Recall initiation date
- July 18, 2012
- Center classification date
- April 2, 2013
- Code info
- Lot #: 835H, Exp 07/12
- More code info
- —