Recalls / Class III
Class IIID-1044-2014
Product
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.
- Brand name
- Ketoconazole
- Generic name
- Ketoconazole
- Active ingredient
- Ketoconazole
- Route
- Topical
- NDC
- 0168-0099
- FDA application
- ANDA076294
- Affected lot / code info
- Lot #: 495P, Exp 07/14
Why it was recalled
Failed Impurities/Degradation Specifications: Out-of-Specification degradant results.
Recalling firm
- Firm
- Fougera Pharmaceuticals Inc.
- Manufacturer
- E. Fougera & Co. a division of Fougera Pharmaceuticals, LLC
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 60 Baylis Rd, Melville, New York 11747-3838
Distribution
- Quantity
- 31,122 tubes
- Distribution pattern
- Nationwide and Puerto Rico
Timeline
- Recall initiated
- 2013-11-18
- FDA classified
- 2014-01-30
- Posted by FDA
- 2014-02-05
- Terminated
- 2016-05-09
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-1044-2014. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.