Drug product
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
D-0612-2017
Product summary
- Event
- Event 76611
- Status
- Terminated
- Classification
- Class II
- Quantity
- 14,665 tubes
- Official record key
drug-enforcement:D-0612-2017
Official wording
Reason: Labeling: Label Mixup; Unit boxes labeled as Desonide Ointment 0.05% may contain tubes of Desonide Ointment labeled as Ketoconazole Cream
Code information: Lot GC9231 (exp. 05/2019); Lot GC9232 (exp. 05/2019)
Distribution pattern: Nationwide
Derived failure modes
-
Labeling or packaging
Labeling: Label Mixup