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
Reported: April 10, 2013 Initiated: July 18, 2012 #D-241-2013
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
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
Details
- Recalling Firm
- Fougera Pharmaceuticals Inc.
- Units Affected
- 60,210 units
- Distribution
- Nationwide
- Location
- Melville, NY
Frequently Asked Questions
What product was recalled? ▼
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. Recalled by Fougera Pharmaceuticals Inc.. Units affected: 60,210 units.
Why was this product recalled? ▼
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
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on April 10, 2013. Severity: Low. Recall number: D-241-2013.
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