Reported Apr 10, 2013 · Terminated
Fougera Ketoconazole Cream 2%, 15g tube, Rx only, Labeled with E. Fougera & Co., a division of Fougera Pharmaceuticals…
Fougera Pharmaceuticals Inc.
Low riskThis product is unlikely to cause harm, but it breaks a safety or labelling rule.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Fougera Pharmaceuticals Inc. · 60 Baylis Road · Melville, NY · 11747-0103
Is this the product you have?
- 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
- Lot codes and dates
Lot #: 835HExp 07/12
- Amount recalled
- 60,210 units
Where it was sold
- Nationwide
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
This product is unlikely to cause harm, but it breaks a safety or labelling rule.
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