Lotrimin Af
Chemical Contamination: presence of benzene
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Chemical Contamination: presence of benzene
Chemical Contamination: presence of benzene
cGMP Deviations: manufactured at the same facility where other lots were found to be contaminated with benzene.
cGMP Deviations: manufactured at the same facility where other lots were found to be contaminated with benzene.
cGMP Deviations: manufactured at the same facility where other lots were found to be contaminated with benzene.
cGMP Deviations: manufactured at the same facility where other lots were found to be contaminated with benzene.
cGMP Deviations: manufactured at the same facility where other lots were found to be contaminated with benzene.
cGMP Deviations: manufactured at the same facility where other lots were found to be contaminated with benzene.
cGMP Deviations: manufactured at the same facility where other lots were found to be contaminated with benzene.
cGMP Deviations: manufactured at the same facility where other lots were found to be contaminated with benzene.
cGMP Deviations: manufactured at the same facility where other lots were found to be contaminated with benzene.
cGMP Deviations: manufactured at the same facility where other lots were found to be contaminated with benzene.
cGMP Deviations
cGMP Deviations
cGMP Deviations
Chemical contamination; presence of benzene
Chemical contamination; presence of benzene
Chemical contamination; presence of benzene
Chemical contamination; presence of benzene
Chemical contamination; presence of benzene
Failed Dissolution Specifications
Lack of Assurance of Sterility: Air filter failed post integrity test leading to a lack of sterility assurance.
SUBPOTENT DRUG: Vial contained a liquid substance, instead of the expected powder substance. There was also a lack of full drug effect upon administration.
Finished product specification did not meet USP specifications.
Lack of Assurance of Sterility