FDAFDA · Food and drugs·Recall number D-1044-2014
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.
Published February 5, 2014 · Recall initiated: November 18, 2013
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Failed Impurities/Degradation Specifications: Out-of-Specification degradant results.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Brand
- KETOCONAZOLE
- Manufacturer
- Fougera Pharmaceuticals Inc.
- Distributor
- Nationwide and Puerto Rico
- UPC
- 0301680099156
- Lot
- Lot #: 495P, Exp 07/14
- Risk classification
- Class III
- Area (FDA)
- drug
- Country
- United States
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