Class II · Moderate risk Terminated
Tinactin
Reason cGMP Deviations: manufactured at the same facility where other lots were found to be contaminated with benzene.
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Class II · Moderate risk Terminated
Lotrimin AF
Reason cGMP Deviations: manufactured at the same facility where other lots were found to be contaminated with benzene.
Class II · Moderate risk Terminated
Lotrimin Af
Reason cGMP Deviations: manufactured at the same facility where other lots were found to be contaminated with benzene.
Class II · Moderate risk Terminated
Lotrimin Af
Reason cGMP Deviations: manufactured at the same facility where other lots were found to be contaminated with benzene.
Class II · Moderate risk Terminated
Lotrimin Af
Reason cGMP Deviations: manufactured at the same facility where other lots were found to be contaminated with benzene.
Class II · Moderate risk Terminated
Lotrimin Af
Reason cGMP Deviations: manufactured at the same facility where other lots were found to be contaminated with benzene.
Class II · Moderate risk Terminated
Lotrimin Af
Reason cGMP Deviations: manufactured at the same facility where other lots were found to be contaminated with benzene.
Class II · Moderate risk Terminated
Coppertone Pure & Simple baby 50 Sunscreen Spray
Reason cGMP Deviations
Class II · Moderate risk Terminated
Coppertone Pure & Simple kids 50 Sunscreen Spray
Reason cGMP Deviations
Class II · Moderate risk Terminated
Coppertone Pure & Simple 50 Sunscreen Spray
Reason cGMP Deviations
Class I · High risk Terminated
Coppertone SPORT Sunscreen Spray 50
Reason Chemical contamination; presence of benzene
Class I · High risk Terminated
Coppertone SPORT MINERAL 50 Sunscreen Spray
Reason Chemical contamination; presence of benzene
Class I · High risk Terminated
Coppertone Pure & Simple baby 50 Sunscreen Spray
Reason Chemical contamination; presence of benzene
Class I · High risk Terminated
Coppertone Pure & Simple kids 50 Sunscreen Spray
Reason Chemical contamination; presence of benzene
Class I · High risk Terminated
Coppertone Pure & Simple 50 Sunscreen Spray
Reason Chemical contamination; presence of benzene
Class II · Moderate risk Terminated
Potassium Chloride Extended-Release Tablets
Reason Failed Dissolution Specifications
Class II · Moderate risk Terminated
Artesunate for Injection
Reason Lack of Assurance of Sterility: Air filter failed post integrity test leading to a lack of sterility assurance.
Class I · High risk Terminated
Glucagon Emergency Kit for Low Blood Sugar
Reason SUBPOTENT DRUG: Vial contained a liquid substance, instead of the expected powder substance. There was also a lack of full drug effect upon administration.
Class II · Moderate risk Terminated
Hydroquinone USP
Reason Finished product specification did not meet USP specifications.
Class II · Moderate risk Terminated
Testosterone Cypionate Testosterone Propionate
Reason Lack of Assurance of Sterility
Class II · Moderate risk Terminated
AirDuo Digihaler 232/14
Reason Subpotent drug: OOS results of Label Claimed Emitted Dose for salmeterol
Class II · Moderate risk Terminated
AirDuo Digihaler 113/14
Reason Subpotent drug: OOS results of Label Claimed Emitted Dose for salmeterol
Class II · Moderate risk Terminated
AirDuo Digihaler 55/14
Reason Subpotent drug: OOS results of Label Claimed Emitted Dose for salmeterol
Class II · Moderate risk Terminated
AirDuo Digihaler 232/14
Reason Subpotent drug: OOS results of Label Claimed Emitted Dose for salmeterol
Class II · Moderate risk Terminated
AirDuo Digihaler 113/14
Reason Subpotent drug: OOS results of Label Claimed Emitted Dose for salmeterol