Recalls / Class III
Class IIID-241-2013
Product
Fougera Ketoconazole Cream 2%, 15g tube, Rx only, Labeled with E. Fougera & Co., a division of Fougera Pharmaceuticals Inc., Melville, New York 11747, NDC 0168-0099-15
- Brand name
- Ketoconazole
- Generic name
- Ketoconazole
- Active ingredient
- Ketoconazole
- Route
- Topical
- NDC
- 0168-0099
- FDA application
- ANDA076294
- Affected lot / code info
- Lot #: 835H, Exp 07/12
Why it was recalled
Failed Impurities/Degradation Specifications: Ketoconazole Cream 2% is the subject of a voluntary drug recall by Fougera due to an Out Of Specification result for an unknown degradant product
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 Road, N/A, Melville, New York 11747-0103
Distribution
- Quantity
- 60,210 units
- Distribution pattern
- Nationwide
Timeline
- Recall initiated
- 2012-07-18
- FDA classified
- 2013-04-02
- Posted by FDA
- 2013-04-10
- Terminated
- 2015-12-10
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-241-2013. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.