Class III · Low risk Terminated
Lisinopril & Hydrochlorothiazide Tables
Reason CGMP Deviations: finished products manufactured using active pharmaceutical ingredients whose intermediates failed specifications.
FDA Drug Recalls
14,801 recalls, newest first
Class II · Moderate risk Terminated
Better Braids Un-Braid
Reason Microbial Contamination of Non-Sterile Products: Failed S.aureus test.
Class III · Low risk Terminated
¿Topicort
Reason Subpotent Drug
Class III · Low risk Terminated
Fenofibrate Capsules
Reason Labeling: Incorrect or Missing Lot and/or Exp Date
Class III · Low risk Terminated
Fenofibrate Capsules
Reason Labeling: Incorrect or Missing Lot and/or Exp Date
Class III · Low risk Terminated
Intermezzo
Reason Failed Dissolution Specifications
Class I · High risk Terminated
PHENYLephrine 1 mg/10 mL
Reason Labeling: Label Error on Declared Strength. Product has correct label on the syringe and the case but some units are incorrectly labeled as .4 mg/10 mL (40 mcg/ml) on the light protective overwrap of each syringe.
Class II · Moderate risk Terminated
Ondansetron Tablets USP
Reason Failed Impurities/Degradation Specifications; 12 month stability time point
Class II · Moderate risk Terminated
All Malarone
Reason Lack of Processing Controls
Class II · Moderate risk Terminated
All potassium bromide Products
Reason Lack of Processing Controls
Class II · Moderate risk Terminated
All baclofen Products
Reason Lack of Processing Controls
Class II · Moderate risk Terminated
All diethylstilbestrol Products
Reason Lack of Processing Controls
Class II · Moderate risk Terminated
All e2-e3-p4 Products
Reason Lack of Processing Controls
Class II · Moderate risk Terminated
All tacrolimus Products
Reason Lack of Processing Controls
Class II · Moderate risk Terminated
All Nitro Paste
Reason Lack of Processing Controls
Class II · Moderate risk Terminated
All hydroquinone Products
Reason Lack of Processing Controls
Class II · Moderate risk Terminated
All clobetasol Products
Reason Lack of Processing Controls
Class II · Moderate risk Terminated
All methyltestosterone Products
Reason Lack of Processing Controls
Class II · Moderate risk Terminated
All ketamine and amitriptyline Products
Reason Lack of Processing Controls
Class II · Moderate risk Terminated
All estradiol Products
Reason Lack of Processing Controls
Class II · Moderate risk Terminated
All dyclonine Products
Reason Lack of Processing Controls
Class II · Moderate risk Terminated
All doxycycline Products
Reason Lack of Processing Controls
Class II · Moderate risk Terminated
All sucralfate Products
Reason Lack of Processing Controls
Class II · Moderate risk Terminated
All fluconazole Products
Reason Lack of Processing Controls
Class II · Moderate risk Terminated
All acyclovir and lidocaine Products
Reason Lack of Processing Controls