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Ketoconazole

FDA recalls

3 rows

DateCompany and reasonClass
Apr 12, 2022McKesson Medical-Surgical Inc. Corporate Office
cGMP deviations: Temperature abuse		Class II · Terminated
Nov 17, 2013Fougera Pharmaceuticals Inc.
Failed Impurities/Degradation Specifications: Out-of-Specification degradant results.		Class III · Terminated
Jul 17, 2012Fougera Pharmaceuticals Inc.
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		Class III · Terminated

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Sources: CMS Medicare Part D Prescribers 2024; CMS Open Payments 2025 (general payments; a payment is not evidence of wrongdoing); FDA enforcement reports (openFDA).