FDA-Drug2014-02-05Class III
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.
Fougera Pharmaceuticals Inc.
Hazard
Failed Impurities/Degradation Specifications: Out-of-Specification degradant results.
Sold states
Nationwide and Puerto Rico
Affected count
31,122 tubes
Manufactured in
60 Baylis Rd, Melville, NY, United States
Products
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.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1044-2014Don't want to check this manually?
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