Class II
Terminated
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
This recall has been terminated (originally issued March 29, 2017).
- Company
- Fougera Pharmaceuticals Inc.
- Recall Initiated
- March 2, 2017
- Posted
- March 29, 2017
- Recall Number
- D-0612-2017
- Voluntary / Mandated
- Voluntary: Firm initiated
- Quantity
- 14,665 tubes
- Firm Location
- Melville, NY, United States
- Official Source
- View on FDA website ↗
Reason for Recall
Labeling: Label Mixup; Unit boxes labeled as Desonide Ointment 0.05% may contain tubes of Desonide Ointment labeled as Ketoconazole Cream
Distribution
Nationwide
Lot / Code Info
Lot GC9231 (exp. 05/2019); Lot GC9232 (exp. 05/2019)
More recalls by Fougera Pharmaceuticals Inc.
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