Class II · Moderate risk Ongoing
BusPIRone Hydrochloride Tablets USP
Reason CGMP Deviations
FDA Drug Recalls
14,450 recalls · Class II, newest first
Class II · Moderate risk Ongoing
Atorvastatin Calcium Tablets
Reason CGMP Deviations
Class II · Moderate risk Terminated
Verapamil Hydrochloride Extended-Release Tablets
Reason Failed Dissolution Specifications: Out of specification dissolution results above specified values.
Class II · Moderate risk Completed
Dianeal PD-2 Peritonial Dialysis Solution with 1.5% Dextrose
Reason Lack of Assurance of Sterility: Potential presence of leaks originating from the Luer component.
Class II · Moderate risk Completed
Dianeal Low Calcium
Reason Lack of Assurance of Sterility: Potential presence of leaks originating from the Luer component.
Class II · Moderate risk Ongoing
Dabigatran Etexilate 150mg Capsules
Reason CGMP Deviations: Detection of N-nitroso-dabigatran (NDAB) impurity levels above the Acceptable Daily Intake Limit.
Class II · Moderate risk Ongoing
Dabigatran Etexilate Capsules
Reason CGMP Deviations: Detection of N-nitroso-dabigatran (NDAB) impurity levels above the Acceptable Daily Intake Limit.
Class II · Moderate risk Ongoing
Pantoprazole Sodium Delayed Release Tablets USP 40mg
Reason CGMP Deviations: Discoloration
Class II · Moderate risk Terminated
Simvastatin
Reason cGMP deviations
Class II · Moderate risk Terminated
Simvastatin
Reason cGMP deviations
Class II · Moderate risk Terminated
Simvastatin
Reason cGMP deviations
Class II · Moderate risk Terminated
Simvastatin
Reason cGMP deviations
Class II · Moderate risk Terminated
Glimepiride
Reason cGMP deviations
Class II · Moderate risk Terminated
Glimepiride
Reason cGMP deviations
Class II · Moderate risk Terminated
Glimepiride
Reason cGMP deviations
Class II · Moderate risk Terminated
Ropinirole
Reason cGMP deviations
Class II · Moderate risk Terminated
Ropinirole
Reason cGMP deviations
Class II · Moderate risk Terminated
Finasteride
Reason cGMP deviations
Class II · Moderate risk Terminated
Montelukast Sodium Tablets
Reason cGMP deviations
Class II · Moderate risk Ongoing
Daytrana
Reason Defective Delivery System: Out of specification for shear.
Class II · Moderate risk Ongoing
Daytrana
Reason Defective Delivery System: Out of specification for shear.
Class II · Moderate risk Ongoing
Daytrana
Reason Defective Delivery System: Out of specification for shear.
Class II · Moderate risk Ongoing
Daytrana
Reason Defective Delivery System: Out of specification for shear.
Class II · Moderate risk Terminated
Jardiance
Reason Labeling: Label Mix-up
Class II · Moderate risk Terminated
Calcitonin Salmon Nasal Spray
Reason Failed Impurities/Degradation Specifications and Subpotent Drug: High Out of Specification results for a known and unknown impurity as well as low Out of Specification results for assay.