drugs Class III Updated 2013-04-10

Fougera Pharmaceuticals Inc. recalls Fougera Ketoconazole Cream 2%, 15g tube, Rx only, Labeled wi

Recalled 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

Hazard / Issue

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

Issued by

FDA

Distribution: Nationwide (United States)
Lot/Code Info: Lot #: 835H, Exp 07/12
View official government recall

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