FDAFDA · Food and drugs·Recall number D-0612-2017
Desonide Ointment, 0.05%, NET WT 60 grams tubes, Rx only, E. FOUGERA & CO. A division of Fougera Pharmaceuticals Inc., Melville, New York 11747, NDC 0168-0309-60
Published March 29, 2017 · Recall initiated: March 2, 2017
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
Labeling: Label Mixup; Unit boxes labeled as Desonide Ointment 0.05% may contain tubes of Desonide Ointment labeled as Ketoconazole Cream
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Fougera Pharmaceuticals Inc.
- Distributor
- Nationwide
- Lot
- Lot GC9231 (exp. 05/2019); Lot GC9232 (exp. 05/2019)
- Risk classification
- Class II
- Area (FDA)
- drug
- Country
- United States
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