Class II · Moderate risk
Glimepiride
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
Ropinirole
cGMP deviations
Class II · Moderate risk
Ropinirole
cGMP deviations
Class II · Moderate risk
Finasteride
cGMP deviations
Class II · Moderate risk
Montelukast Sodium Tablets
cGMP deviations
Class II · Moderate risk
Daytrana (methylphenidate transdermal system)
Defective Delivery System: Out of specification for shear.
Class II · Moderate risk
Daytrana (methylphenidate transdermal system)
Defective Delivery System: Out of specification for shear.
Class II · Moderate risk
Daytrana (methylphenidate transdermal system)
Defective Delivery System: Out of specification for shear.
Class II · Moderate risk
Daytrana (methylphenidate transdermal system)
Defective Delivery System: Out of specification for shear.
Class II · Moderate risk
JARDIANCE (Empagliflozin)
Labeling: Label Mix-up
Class II · Moderate risk
Calcitonin Salmon Nasal Spray
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.
Class II · Moderate risk
Clobazam Tablets
CGMP Deviations: Potential risk of Cross Contamination
Class II · Moderate risk
Clobazam Tablets
CGMP Deviations: Potential risk of Cross Contamination
Class II · Moderate risk
Alprazolam Tablets
CGMP Deviations: Potential risk of Cross Contamination
Class II · Moderate risk
Alprazolam Tablets
CGMP Deviations: Potential risk of Cross Contamination
Class II · Moderate risk
Alprazolam Tablets
CGMP Deviations: Potential risk of Cross Contamination
Class II · Moderate risk
Alprazolam Tablets
CGMP Deviations: Potential risk of Cross Contamination
Class II · Moderate risk
Heparin Sodium
Subpotent Drug: low Anti-Factor IIa potency.
Class II · Moderate risk
Brimonidine Tartrate Ophthalmic Solution 0.15%
Lack of sterility assurance: Cracks have developed in some of the units caps of Brimonidine tartrate ophthalmic solution bottles. There is a possibility the broken cap may impact sterility.
Class II · Moderate risk
Heparin Sodium Injection
Labeling: Not elsewhere classified
Class II · Moderate risk
Class II · Moderate risk
Activator Concentrate
CGMP DEVIATIONS
Class II · Moderate risk
Nose Better Gel
CGMP DEVIATIONS
Class II · Moderate risk
Soltice Quick-RUB
CGMP DEVIATIONS
Class II · Moderate risk
Unguentine Original Ointment for Burns
CGMP DEVIATIONS