Class II · Moderate risk Terminated
Dr. Reddy's Ezetimibe and Simvastatin Tablets
Reason Failed Excipient Specifications; product manufactured using an excipient found to be OOS for conductivity
FDA Drug Recalls
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Class II · Moderate risk Terminated
Dr. Reddy's Ezetimibe and Simvastatin Tablets
Reason Failed Excipient Specifications; product manufactured using an excipient found to be OOS for conductivity
Class II · Moderate risk Terminated
Omeprazole Delayed-Release Capsules
Reason CGMP Deviations: Customer complaint for the presence of a staple co-mingled with capsules within the bottle.
Class II · Moderate risk Terminated
Betaxolol Ophthalmic Solution
Reason Microbial Contamination of Sterile Products: Confirmed sterility failure identified during stability testing at the 12-month time point.
Class II · Moderate risk Terminated
Lotrimin Af
Reason cGMP Deviations: LOTRIMIN AF (Tolnaftate 1%) manufactured at the same facility where other lots were found to be contaminated with benzene.
Class I · High risk Terminated
Tinactin
Reason Chemical Contamination: presence of benzene
Class I · High risk Terminated
Tinactin
Reason Chemical Contamination: presence of benzene
Class I · High risk Terminated
Tinactin
Reason Chemical Contamination: presence of benzene
Class I · High risk Terminated
Tinactin
Reason Chemical Contamination: presence of benzene
Class I · High risk Terminated
Lotrimin AF
Reason Chemical Contamination: presence of benzene
Class I · High risk Terminated
Lotrimin Af
Reason Chemical Contamination: presence of benzene
Class I · High risk Terminated
Lotrimin Af
Reason Chemical Contamination: presence of benzene
Class I · High risk Terminated
Lotrimin Af
Reason Chemical Contamination: presence of benzene
Class II · Moderate risk Terminated
Tinactin
Reason cGMP Deviations: manufactured at the same facility where other lots were found to be contaminated with benzene.
Class II · Moderate risk Terminated
Tinactin
Reason cGMP Deviations: manufactured at the same facility where other lots were found to be contaminated with benzene.
Class II · Moderate risk Terminated
Tinactin
Reason cGMP Deviations: manufactured at the same facility where other lots were found to be contaminated with benzene.
Class II · Moderate risk Terminated
Tinactin
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
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