Recalls / Class II
Class IID-0612-2017
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
- Affected lot / code info
- Lot GC9231 (exp. 05/2019); Lot GC9232 (exp. 05/2019)
Why it was recalled
Labeling: Label Mixup; Unit boxes labeled as Desonide Ointment 0.05% may contain tubes of Desonide Ointment labeled as Ketoconazole Cream
Recalling firm
- Firm
- Fougera Pharmaceuticals Inc.
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 60 Baylis Rd, Melville, New York 11747-3838
Distribution
- Quantity
- 14,665 tubes
- Distribution pattern
- Nationwide
Timeline
- Recall initiated
- 2017-03-02
- FDA classified
- 2017-03-23
- Posted by FDA
- 2017-03-29
- Terminated
- 2018-07-02
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0612-2017. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.