Class II · Moderate risk
Duloxetine Delayed-Release Capsules
CGMP Deviations; presence of N-nitroso-duloxetine impurity above recommended interim limit.
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
Cinacalcet Tablets
CGMP deviations: Presence of Nitrosamine Drug Substance Related Impurity (NDSRI), N-Nitroso-Cinacalcet above acceptable intake limit.
Class II · Moderate risk
Cinacalcet Tablets
CGMP deviations: Presence of Nitrosamine Drug Substance Related Impurity (NDSRI), N-Nitroso-Cinacalcet above acceptable intake limit.
Class II · Moderate risk
Cinacalcet Tablets
CGMP deviations: Presence of Nitrosamine Drug Substance Related Impurity (NDSRI), N-Nitroso-Cinacalcet above acceptable intake limit.
Class II · Moderate risk
Kit for the Preparation of Technetium Tc 99m Sestamibi Injection
Lack of Assurance of Sterility; Improper crimps on vials impacting the integrity of the product
Class II · Moderate risk
Olanzapine Tablets
Failed Impurities/Degradation Specifications
Class II · Moderate risk
Kit for the Preparation of Technetium Tc 99m Sulfur Colloid Injection
Failed Stability Specifications
Class II · Moderate risk
VCF, Vaginal Contraceptive Gel
CGMP deviations: out of specifications for assay
Class II · Moderate risk
Dihydroergotamine Mesylate Injection
Discoloration
Class II · Moderate risk
10 Irregular Pigmentation
CGMP Deviations: Inconsistency in the water systems.
Class II · Moderate risk
Levothyroxine Sodium Tablets
Subpotent and Superpotent Drug
Class II · Moderate risk
Levothyroxine Sodium Tablets
Subpotent and Superpotent Drug
Class II · Moderate risk
Levothyroxine Sodium Tablets
Subpotent and Superpotent Drug
Class II · Moderate risk
Levothyroxine Sodium Tablets
Subpotent and Superpotent Drug
Class II · Moderate risk
Levothyroxine Sodium Tablets
Subpotent and Superpotent Drug
Class II · Moderate risk
Levothyroxine Sodium Tablets
Subpotent and Superpotent Drug
Class II · Moderate risk
Duloxetine DR Capsules USP 60 mg
CGMP Deviations: Presence of N-nitroso-duloxetine impurity above recommended interim limit
Class II · Moderate risk
Duloxetine Delayed-Release Capsules USP
CGMP Deviations: Presence of N-nitroso-duloxetine impurity above recommended interim limit
Class II · Moderate risk
Duloxetine Delayed-Release Capsules USP
CGMP Deviations: Presence of N-nitroso-duloxetine impurity above recommended interim limit
Class II · Moderate risk
Levothyroxine Sodium Tablets USP
Superpotent Drug and Subpotent Drug: potency failures obtained
Class II · Moderate risk
Levothyroxine Sodium Tablets USP
Superpotent Drug and Subpotent Drug: potency failures obtained
Class II · Moderate risk
Levothyroxine Sodium Tablets USP
Superpotent Drug and Subpotent Drug: potency failures obtained
Class II · Moderate risk
Levothyroxine Sodium Tablets USP
Superpotent Drug and Subpotent Drug: potency failures obtained
Class II · Moderate risk
Levothyroxine Sodium Tablets USP
Superpotent Drug and Subpotent Drug: potency failures obtained
Class II · Moderate risk
Levothyroxine Sodium Tablets USP
Superpotent Drug and Subpotent Drug: potency failures obtained