10 FDA recalls mention Ketoconazole. The most recent are listed below.
Recalls are matched by product description. A recall usually affects specific lots, not every package of Ketoconazole.
Reason Failed Viscosity specification: Slightly higher OOS results obtained for viscosity
Reason cGMP deviations: Temperature abuse
Reason CGMP Deviations: Lack of stability data and controls to support the manufacturers assigned retest or expiration date in firm's container/closure…
Reason Lack of Assurance of Sterility: There are also CGMP Deviations.
Reason Lack of Assurance of Sterility: There are also CGMP Deviations.
Reason Lack of Assurance of Sterility: There are also CGMP Deviations.
Reason Penicillin Cross Contamination: All lots of all products repackaged and distributed between 01/05/12 and 02/12/15 are being recalled because they…
Reason Failed Impurities/Degradation Specifications: Out-of-Specification degradant results.
Reason Subpotent
Reason Failed Impurities/Degradation Specifications: Ketoconazole Cream 2% is the subject of a voluntary drug recall by Fougera due to an Out Of…
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