Class II · Moderate risk
Atorvastatin 10 mg tablets
cGMP Deviations
Class II drug recalls - moderate risk
Class II means the product may cause temporary or medically reversible harm, and serious harm is unlikely. It is by far the largest recall class - most potency, dissolution and labeling problems land here.
14,535 recalls, newest first.
Class II · Moderate risk
Aripiprazole 5mg tablets
cGMP Deviations
Class II · Moderate risk
Glimepiride Tablets
CGMP Deviations: recalling drug products following an FDA inspection.
Class II · Moderate risk
Glimepiride Tablets
CGMP Deviations: recalling drug products following an FDA inspection.
Class II · Moderate risk
Glimepiride Tablets
CGMP Deviations: recalling drug products following an FDA inspection.
Class II · Moderate risk
Aripiprazole Tablets
Out of specification (OOS) for Spectroscopic Identification test by IR.
Class II · Moderate risk
Tadalafil Tablets
CGMP Deviations
Class II · Moderate risk
Tadalafil Tablets
CGMP Deviations
Class II · Moderate risk
Glimepiride Tablets
CGMP Deviations
Class II · Moderate risk
Glimepiride Tablets
CGMP Deviations
Class II · Moderate risk
Doxazosin Tablets
CGMP Deviations
Class II · Moderate risk
BusPIRone Hydrochloride Tablets USP
CGMP Deviations
Class II · Moderate risk
Atorvastatin Calcium Tablets
CGMP Deviations
Class II · Moderate risk
Verapamil Hydrochloride Extended-Release Tablets
Failed Dissolution Specifications: Out of specification dissolution results above specified values.
Class II · Moderate risk
Dianeal PD-2 Peritonial Dialysis Solution with 1.5% Dextrose
Lack of Assurance of Sterility: Potential presence of leaks originating from the Luer component.
Class II · Moderate risk
Dianeal Low Calcium
Lack of Assurance of Sterility: Potential presence of leaks originating from the Luer component.
Class II · Moderate risk
Dabigatran Etexilate 150mg Capsules
CGMP Deviations: Detection of N-nitroso-dabigatran (NDAB) impurity levels above the Acceptable Daily Intake Limit.
Class II · Moderate risk
Dabigatran Etexilate Capsules
CGMP Deviations: Detection of N-nitroso-dabigatran (NDAB) impurity levels above the Acceptable Daily Intake Limit.
Class II · Moderate risk
Pantoprazole Sodium Delayed Release Tablets USP 40mg
CGMP Deviations: Discoloration
Class II · Moderate risk
Simvastatin
cGMP deviations
Class II · Moderate risk
Simvastatin
cGMP deviations
Class II · Moderate risk
Simvastatin
cGMP deviations
Class II · Moderate risk
Simvastatin
cGMP deviations
Class II · Moderate risk
Glimepiride
cGMP deviations
Class II · Moderate risk
Glimepiride
cGMP deviations