drugs Class III Updated 2014-02-05

Fougera Pharmaceuticals Inc. recalls KETOCONAZOLE CREAM, 2%, 30 gram tube, Rx only, E. FOUGERA &

Recalled Product

KETOCONAZOLE CREAM, 2%, 30 gram tube, Rx only, E. FOUGERA & CO., A division of Fougera Pharmaceuticals Inc., Melville, New York 11747, NDC 0168-0099-30, UPC 3 0168-0099-30 9.

Hazard / Issue

Failed Impurities/Degradation Specifications: Out-of-Specification degradant results.

Issued by

FDA

Distribution: Nationwide (United States)
Lot/Code Info: Lot #: 495P, Exp 07/14
View official government recall

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