Fougera Pharmaceuticals Inc. recalls KETOCONAZOLE CREAM, 2%, 30 gram tube, Rx only, E. FOUGERA & CO., A division of Fougera Pharmaceuticals Inc., Melville, N
Recalled February 5, 2014 · FDA recall D-1044-2014 · Fougera Pharmaceuticals
Hazard
Failed Impurities/Degradation Specifications: Out-of-Specification degradant results. · FDA Class III
Units
31,122 tubes
Sold at
Nationwide and Puerto Rico
Description
Failed Impurities/Degradation Specifications: Out-of-Specification degradant results.
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.
Manufacturer(s)
Fougera Pharmaceuticals Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →