Reported Feb 5, 2014 · Terminated
KETOCONAZOLE CREAM, 2%, 30 gram tube, Rx only, E. FOUGERA & CO., A division of Fougera Pharmaceuticals Inc., Melville,…
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 Rd · Melville, NY · 11747-3838
Is this the product you have?
- 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 codes and dates
Lot #: 495PExp 07/14
- Amount recalled
- 31,122 tubes
Where it was sold
- Nationwide
- PR
Why it was recalled
Failed Impurities/Degradation Specifications: Out-of-Specification degradant results.
This product is unlikely to cause harm, but it breaks a safety or labelling rule.
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