Class II · Moderate risk Terminated
Blue Tree Lipo Extreme
Reason Lack of assurance of sterility
FDA Drug Recalls
17,898 recalls, newest first
Class II · Moderate risk Terminated
Bi-Mix Papaverine 40/Phentolamine 2 Inj Injectable
Reason Lack of assurance of sterility
Class II · Moderate risk Terminated
B Complex Inj Cmp-No B12
Reason Lack of assurance of sterility
Class II · Moderate risk Terminated
Alprostadil 45mcg/Ml 45mcg/Ml Injectable
Reason Lack of assurance of sterility
Class II · Moderate risk Terminated
Alprostadil 40mcg/Ml Inj 40mcg/Ml Injectable
Reason Lack of assurance of sterility
Class II · Moderate risk Terminated
Alprostadil 32mcg/Ml 32mcg/Ml Injectable
Reason Lack of assurance of sterility
Class II · Moderate risk Terminated
Alprostadil 30mcg/Ml Inj 30mcg/Ml Injectable
Reason Lack of assurance of sterility
Class II · Moderate risk Terminated
Alprostadil 25mcg/Ml 25mcg/Ml Injectable
Reason Lack of assurance of sterility
Class II · Moderate risk Terminated
Alprostadil 22mcg/Ml 22mcg/Ml Injectable
Reason Lack of assurance of sterility
Class II · Moderate risk Terminated
Alprostadil 22.5mcg/Ml 22.5mcg/Ml Injectable
Reason Lack of assurance of sterility
Class II · Moderate risk Terminated
(well's Lipo-Lean)inositol/Choline/B-Comp+leucine+carn+…
Reason Lack of assurance of sterility
Class II · Moderate risk Terminated
Estradiol Valerate 20 mg/mL in Ethyl Oleate Inj. 20 mg/mL Injection in vials
Reason Lack of assurance of sterility
Class I · High risk Completed
Methocarbamol 500mg Tablet
Reason Labeling: Label Error on Declared Strength; Bottles labeled as Methocarbamol 500 mg Tablets actually contain Methocarbamol 750 mg Tablets
Class II · Moderate risk Terminated
Irbesartan and Hydrochlorothiazide Tablets USP
Reason CGMP Deviations: impurity N-nitrosoirbesartan detected in API
Class II · Moderate risk Terminated
Irbesartan and Hydrochlorothiazide Tablets USP
Reason CGMP Deviations: impurity N-nitrosoirbesartan detected in API
Class II · Moderate risk Terminated
Irbesartan Tablets USP
Reason CGMP Deviations: impurity N-nitrosoirbesartan detected in API
Class II · Moderate risk Terminated
Irbesartan Tablets USP
Reason CGMP Deviations: impurity N-nitrosoirbesartan detected in API
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