FDA-Drug2013-04-10Class III
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
Fougera Pharmaceuticals Inc.
Hazard
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
Sold states
Nationwide
Affected count
60,210 units
Manufactured in
60 Baylis Road, N/A, Melville, NY, United States
Products
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
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-241-2013Don't want to check this manually?
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