Recall: D-1044-2014

Class III - Minor Violations

Class IIIClassification

2013-11-18Initiated

TerminatedStatus

Fougera Pharmaceuticals Inc.Firm

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.

Reason

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

Distribution

Nationwide and Puerto Rico

Source: FDA drug enforcement report via openFDA (Voluntary: Firm initiated). If you take this product, talk to your pharmacist or doctor before stopping it.