Class II · Moderate risk Terminated
Irbesartan Tablets USP
Reason CGMP Deviations: impurity N-nitrosoirbesartan detected in API
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Class II · Moderate risk Terminated
Irbesartan Tablets USP
Reason CGMP Deviations: impurity N-nitrosoirbesartan detected in API
Class III · Low risk Terminated
AllerClear D-24 hr
Reason Failed Moisture Limits
Class III · Low risk Terminated
Loratadine-D Extended-Release Tablets
Reason Failed Moisture Limits
Class II · Moderate risk Terminated
Imipramine Pamoate Capsules 125 mg
Reason Out of specification result observed in a dissolution test at the 9-month long term stability time point.
Class III · Low risk Terminated
Cetirizine hydrochloride
Reason Labeling: Not Elsewhere classified: Product was relabeled as 90 tablet count product although it was a manufacturer in a box with 30 tablet count tablets.
Class II · Moderate risk Terminated
Dr. Reddy's Ezetimibe and Simvastatin Tablets
Reason Failed Excipient Specifications and Presence of Foreign Tablets/Capsules; product manufactured using an excipient found to be OOS for conductivity and some Ezetimibe and Simvastatin Tablets, 10 mg/10 mg were found in the bottle
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
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
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
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.