Class II · Moderate risk
Estradiol Valerate 20 mg/mL in Ethyl Oleate Inj. 20 mg/mL Injection in vials
Lack of assurance of sterility
FDA Drug Recalls
921 recalls · Class II, newest first
Class II · Moderate risk
Irbesartan and Hydrochlorothiazide Tablets USP
CGMP Deviations: impurity N-nitrosoirbesartan detected in API
Class II · Moderate risk
Irbesartan and Hydrochlorothiazide Tablets USP
CGMP Deviations: impurity N-nitrosoirbesartan detected in API
Class II · Moderate risk
Irbesartan Tablets USP
CGMP Deviations: impurity N-nitrosoirbesartan detected in API
Class II · Moderate risk
Irbesartan Tablets USP
CGMP Deviations: impurity N-nitrosoirbesartan detected in API
Class II · Moderate risk
Irbesartan Tablets USP
CGMP Deviations: impurity N-nitrosoirbesartan detected in API
Class II · Moderate risk
Imipramine Pamoate Capsules 125 mg
Out of specification result observed in a dissolution test at the 9-month long term stability time point.
Class II · Moderate risk
Dr. Reddy's Ezetimibe and Simvastatin Tablets
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
Dr. Reddy's Ezetimibe and Simvastatin Tablets
Failed Excipient Specifications; product manufactured using an excipient found to be OOS for conductivity
Class II · Moderate risk
Dr. Reddy's Ezetimibe and Simvastatin Tablets
Failed Excipient Specifications; product manufactured using an excipient found to be OOS for conductivity
Class II · Moderate risk
Dr. Reddy's Ezetimibe and Simvastatin Tablets
Failed Excipient Specifications; product manufactured using an excipient found to be OOS for conductivity
Class II · Moderate risk
Dr. Reddy's Ezetimibe and Simvastatin Tablets
Failed Excipient Specifications; product manufactured using an excipient found to be OOS for conductivity
Class II · Moderate risk
Omeprazole Delayed-Release Capsules
CGMP Deviations: Customer complaint for the presence of a staple co-mingled with capsules within the bottle.
Class II · Moderate risk
Betaxolol Ophthalmic Solution
Microbial Contamination of Sterile Products: Confirmed sterility failure identified during stability testing at the 12-month time point.
Class II · Moderate risk
Lotrimin Af
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
Tinactin (Tolnaftate 1%)
cGMP Deviations: manufactured at the same facility where other lots were found to be contaminated with benzene.
Class II · Moderate risk
Tinactin (Tolnaftate 1%)
cGMP Deviations: manufactured at the same facility where other lots were found to be contaminated with benzene.
Class II · Moderate risk
Tinactin (Tolnaftate 1%)
cGMP Deviations: manufactured at the same facility where other lots were found to be contaminated with benzene.
Class II · Moderate risk
Tinactin (Tolnaftate 1%)
cGMP Deviations: manufactured at the same facility where other lots were found to be contaminated with benzene.
Class II · Moderate risk
Lotrimin AF
cGMP Deviations: manufactured at the same facility where other lots were found to be contaminated with benzene.
Class II · Moderate risk
Lotrimin Af
cGMP Deviations: manufactured at the same facility where other lots were found to be contaminated with benzene.
Class II · Moderate risk
Lotrimin Af
cGMP Deviations: manufactured at the same facility where other lots were found to be contaminated with benzene.
Class II · Moderate risk
Lotrimin Af
cGMP Deviations: manufactured at the same facility where other lots were found to be contaminated with benzene.
Class II · Moderate risk
Lotrimin Af
cGMP Deviations: manufactured at the same facility where other lots were found to be contaminated with benzene.
Class II · Moderate risk
Lotrimin Af
cGMP Deviations: manufactured at the same facility where other lots were found to be contaminated with benzene.