Fougera Pharmaceuticals Inc. recalls Fougera Ketoconazole Cream 2%, 15g tube, Rx only, Labeled with E. Fougera & Co., a division of Fougera Pharmaceuticals I
Recalled April 10, 2013 · FDA recall D-241-2013 · Fougera Pharmaceuticals
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 · FDA Class III
Units
60,210 units
Sold at
Nationwide
Description
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
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
Manufacturer(s)
Fougera Pharmaceuticals Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →