Class II · Moderate risk Terminated
Irbesartan Tablets USP
Reason CGMP Deviations: impurity N-nitrosoirbesartan detected in API
FDA Drug Recalls
14,450 recalls · Class II, newest first
Class II · Moderate risk Terminated
Irbesartan Tablets USP
Reason CGMP Deviations: impurity N-nitrosoirbesartan detected in API
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 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 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
Class II · Moderate risk Terminated
Coppertone Pure & Simple 50 Sunscreen Spray
Reason cGMP Deviations
Class II · Moderate risk Ongoing
The Natural Dentist Healthy Balance Peppermint Sage
Reason Labeling; Label mix-up and Wrong Bar Code; back label incorrectly states active ingredient as Menthol with UPC 7 14132 00071 4 instead of Peppermint Oil and Sage Oil with UPC 7 14132 00073 8