Class III · Low risk Terminated
Xolegel
Reason Failed Viscosity specification: Slightly higher OOS results obtained for viscosity
Fougera Ketoconazole Cream 2%
Class III — Low risk. Unlikely to cause harm, but violates FDA regulations.
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
What was recalled
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
- Recalling firm
- Fougera Pharmaceuticals Inc.
- NDC code
- 0168-0099-15
- Origin
- NY, United States
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-241-2013
What should you do? A recall doesn't always mean your specific bottle is affected - it often applies to certain lots only. Check the lot number on your package against the FDA notice, and talk to your pharmacist before stopping any medication.
Other Ketoconazole recalls
See all
Class II · Moderate risk Terminated
Ketoconazole Cream
Reason cGMP deviations: Temperature abuse
Class II · Moderate risk Terminated
Ketoconazole USP for prescription compounding
Reason CGMP Deviations: Lack of stability data and controls to support the manufacturers assigned retest or expiration date in firm's container/closure system.
Class II · Moderate risk Terminated
Reverse Dml Lotion
Reason Lack of Assurance of Sterility: There are also CGMP Deviations.
Class II · Moderate risk Terminated
TACROLIMUS 0.1% Ointment and TACROLIMUS 0.1%/KETOCONAZOLE 2%
Reason Lack of Assurance of Sterility: There are also CGMP Deviations.
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