Class II · Moderate risk
Morphine Sulfate Extended-Release Tablets 15 mg
Failed Impurities/Degradation Specification
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
Chlorpheniramine Maleate 4 mg tablets
Superpotent Drug: Stability failure for assay at 6 months test time-point.
Class II · Moderate risk
Sunitinib Malate Capsules
Labeling: Label Mix-Up
Class II · Moderate risk
Sunitinib Malate Capsules
Labeling: Label Mix-Up
Class II · Moderate risk
Class II · Moderate risk
OneLAX Docusate Sodium Liquid
CGMP Deviations
Class II · Moderate risk
Cinacalcet Tablets
CGMP Deviations: the presence of a nitrosamine impurity, N-nitroso-cinacalcet, above the acceptable daily intake (ADI) limits.
Class II · Moderate risk
Cinacalcet Tablets
CGMP Deviations: the presence of a nitrosamine impurity, N-nitroso-cinacalcet, above the acceptable daily intake (ADI) limits.
Class II · Moderate risk
Cinacalcet Tablets 30 mg
CGMP Deviations: the presence of a nitrosamine impurity, N-nitroso-cinacalcet, above the acceptable daily intake (ADI) limits.
Class II · Moderate risk
Duloxetine Delayed-Release Capsules
CGMP Deviations: Presence of N-nitroso-duloxetine impurity above FDA recommended interim limit
Class II · Moderate risk
Cinacalcet Tablets
CGMP Deviations: Presence of N-nitroso Cinacalcet impurity above FDA recommended interim limit
Class II · Moderate risk
Cinacalcet Tablets
CGMP Deviations: Presence of N-nitroso Cinacalcet impurity above FDA recommended interim limit
Class II · Moderate risk
Cinacalcet Tablets
CGMP Deviations: Presence of N-nitroso Cinacalcet impurity above FDA recommended interim limit
Class II · Moderate risk
Liceout
CGMP violations.
Class II · Moderate risk
Liceout
CGMP violations.
Class II · Moderate risk
AK Forte Ortiga y Omega 3 Cont. Neto 100 Tabletas
Marketed without an Approved NDA/ANDA: FDA analysis found the product to be tainted with undeclared diclofenac and acetaminophen.
Class II · Moderate risk
Cisplatin Injection
Failed Impurities/Degradation Specifications.
Class II · Moderate risk
Thiamine HCl 0.9% Sodium Chloride Injection USP
cGMP violations
Class II · Moderate risk
EPINEPHrine 0.9% Sodium Chloride Injection USP
cGMP violations
Class II · Moderate risk
Oxytocin 0.9% Sodium Chloride Injection USP
cGMP violations
Class II · Moderate risk
NORepinephrine Bitartrate 0.9% Sodium Chloride Injection USP
cGMP violations
Class II · Moderate risk
NORepinephrine Bitartrate 0.9% Sodium Chloride Injection USP
cGMP violations
Class II · Moderate risk
Class II · Moderate risk
Phenylephrine HCl 0.9% Sodium Chloride Injection USP
cGMP violations
Class II · Moderate risk
Phenylephrine HCl 0.9% Sodium Chloride Injection USP
cGMP violations