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.
Reported: February 5, 2014 Initiated: November 18, 2013 #D-1044-2014
Product Description
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.
Reason for Recall
Failed Impurities/Degradation Specifications: Out-of-Specification degradant results.
Details
- Recalling Firm
- Fougera Pharmaceuticals Inc.
- Units Affected
- 31,122 tubes
- Distribution
- Nationwide and Puerto Rico
- Location
- Melville, NY
Frequently Asked Questions
What product was recalled? ▼
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.. Recalled by Fougera Pharmaceuticals Inc.. Units affected: 31,122 tubes.
Why was this product recalled? ▼
Failed Impurities/Degradation Specifications: Out-of-Specification degradant results.
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on February 5, 2014. Severity: Low. Recall number: D-1044-2014.
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