Why it was recalled
Failed Impurities/Degradation Specifications: Out-of-Specification degradant results.
Product description
KETOCONAZOLE CREAM, 2%, 30 gram tube, Rx only, E. FOUGERA & CO., A division of Fougera Pharmaceuticals Inc., Melville, New York 11747, NDC 0168-0099-30, UPC 3 0168-0099-30 9.
Lot numbers, UPCs & expiration codes
Lot #: 495P, Exp 07/14
Where it was sold
Nationwide and Puerto Rico
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-1044-2014
- Classification
- Class III
- Status
- Terminated
- Recall initiated
- Nov 18, 2013
- FDA report date
- Feb 5, 2014
- Quantity
- 31,122 tubes
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Fougera Pharmaceuticals Inc.
Original FDA data
Every field from FDA enforcement report D-1044-2014, exactly as published.
Show all FDA fields
- City
- Melville
- State
- NY
- Status
- Terminated
- Country
- United States
- Event ID
- 66881
- Address
- 60 Baylis Rd
- Code information
- Lot #: 495P, Exp 07/14
- Postal code
- 11747-3838
- Report date
- Feb 5, 2014
- Product type
- Drugs
- Recall number
- D-1044-2014
- Classification
- Class III
- Recalling firm
- Fougera Pharmaceuticals Inc.
- Product quantity
- 31,122 tubes
- Termination date
- May 9, 2016
- Reason for recall
- Failed Impurities/Degradation Specifications: Out-of-Specification degradant results.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- KETOCONAZOLE CREAM, 2%, 30 gram tube, Rx only, E. FOUGERA & CO., A division of Fougera Pharmaceuticals Inc., Melville, New York 11747, NDC 0168-0099-30, UPC 3 0168-0099-30 9.
- Distribution pattern
- Nationwide and Puerto Rico
- Recall initiation date
- Nov 18, 2013
- Initial firm notification
- Letter
- Center classification date
- Jan 30, 2014