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
Product description
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
Lot numbers, UPCs & expiration codes
Lot GC9231 (exp. 05/2019); Lot GC9232 (exp. 05/2019)
Where it was sold
Nationwide
What to do if you have this product
- Compare the lot number and expiration date on your package with the codes above.
- Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
- If you have symptoms you think are related, contact your doctor. In an emergency call 911.
- Report side effects to FDA MedWatch at 1-800-FDA-1088.
Recall details
- Recall number
- D-0612-2017
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Mar 2, 2017
- FDA report date
- Mar 29, 2017
- Quantity
- 14,665 tubes
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Fougera Pharmaceuticals Inc.
Original FDA data
Every field from FDA enforcement report D-0612-2017, exactly as published.
Show all FDA fields
- City
- Melville
- State
- NY
- Status
- Terminated
- Country
- United States
- Event ID
- 76611
- Address
- 60 Baylis Rd
- Code information
- Lot GC9231 (exp. 05/2019); Lot GC9232 (exp. 05/2019)
- Postal code
- 11747-3838
- Report date
- Mar 29, 2017
- Product type
- Drugs
- Recall number
- D-0612-2017
- Classification
- Class II
- Recalling firm
- Fougera Pharmaceuticals Inc.
- Product quantity
- 14,665 tubes
- Termination date
- Jul 2, 2018
- Reason for recall
- Labeling: Label Mixup; Unit boxes labeled as Desonide Ointment 0.05% may contain tubes of Desonide Ointment labeled as Ketoconazole Cream
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- 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
- Distribution pattern
- Nationwide
- Recall initiation date
- Mar 2, 2017
- Initial firm notification
- Letter
- Center classification date
- Mar 23, 2017