FDA recall D-1044-2014

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 for recall

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

Distribution

Nationwide and Puerto Rico

Key facts

Status

Terminated

Initiation date

2013-11-18

Report date

2014-02-05

Termination date

2016-05-09

Voluntary/Mandated

Voluntary: Firm initiated

Location

Melville, NY, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1044-2014