Ketoconazole Cream recall: Impurity Out of Spec
KETOCONAZOLE CREAM, 2%, 30 gram tube, Rx only, E. FOUGERA & CO., A division of Fougera Pharmaceuticals Inc., Melville, New York 11747, NDC…
Why was Ketoconazole Cream recalled?
Failed Impurities/Degradation Specifications: Out-of-Specification degradant results.
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
Lot #: 495P, Exp 07/14
- Product
- KETOCONAZOLE CREAM, 2%, 30 gram tube, Rx only, E. FOUGERA & CO., A division of Fougera Pharmaceuticals Inc., Melville, New York 11747, NDC…
- Recalling firm
- Fougera Pharmaceuticals Inc.
- Quantity
- 31,122 tubes
- Distribution
- Nationwide and Puerto Rico
- Recall date
- February 5, 2014
- Classification
- Class III
- Status
- Terminated
- Agency
- FDA (drug)