Class II · Moderate risk Terminated
Verapamil Hydrochloride Extended-Release Tablets
Reason Failed Dissolution Specifications: Out of specification dissolution results above specified values.
FDA Drug Recalls
17,898 recalls, newest first
Class III · Low risk Ongoing
Epinephrine Professional EMS
Reason Labeling; Incorrect NDC number on outer carton of product.
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 I · High risk Ongoing
Atovaquone Oral Suspension USP
Reason Microbial Contamination of Non-Sterile Product: Objectionable organism, identified as Bacillus cereus, found in product during testing of repackaged product.
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 III · Low risk Terminated
Dofetilide Capsules
Reason Failed Content Uniformity Specifications
Class II · Moderate risk Terminated
Jardiance
Reason Labeling: Label Mix-up