Fougera Ketoconazole Cream 2% recall: Impurity Out of Spec
Fougera Ketoconazole Cream 2%, 15g tube, Rx only, Labeled with E. Fougera & Co., a division of Fougera Pharmaceuticals Inc., Melville, New York 11747…
Why was Fougera Ketoconazole Cream 2% 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 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 #: 835H, Exp 07/12
- Product
- Fougera Ketoconazole Cream 2%, 15g tube, Rx only, Labeled with E. Fougera & Co., a division of Fougera Pharmaceuticals Inc., Melville, New York 11747…
- Recalling firm
- Fougera Pharmaceuticals Inc.
- Quantity
- 60,210 units
- Distribution
- Nationwide
- Recall date
- April 10, 2013
- Classification
- Class III
- Status
- Terminated
- Agency
- FDA (drug)