Class II · Moderate risk
Dabigatran Etexilate
CGMP Deviations: Presence of N-nitroso-Dabigatran impurity above recommended interim limit
FDA Drug Recalls
354 recalls, newest first
Class II · Moderate risk
Dabigatran Etexilate
CGMP Deviations: Presence of N-nitroso-Dabigatran impurity above recommended interim limit
Class II · Moderate risk
chlorproMAZINE Hydrochloride Tablets
CGMP Deviations: N-Nitroso-Desmethyl Chlorpromazine impurity (NNDCI) were found to be failing per current FDA recommended limit.
Class II · Moderate risk
chlorproMAZINE Hydrochloride Tablets
CGMP Deviations: N-Nitroso-Desmethyl Chlorpromazine impurity (NNDCI) were found to be failing per current FDA recommended limit.
Class II · Moderate risk
Dapsone Gel 7.5%
Crystallization
Class II · Moderate risk
Dapsone Gel 7.5%
Crystallization
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
Duloxetine Delayed-Release Capsules
CGMP Deviations: presence of N-nitroso-duloxetine impurity above FDA recommended interim limit.
Class II · Moderate risk
Duloxetine Delayed-Release Capsules
CGMP Deviations: Presence of N-nitroso-duloxetine impurity above the recommended interim limit.
Class II · Moderate risk
Duloxetine Delayed-Release Capsules USP
CGMP Deviations: Presence of N-nitroso-duloxetine impurity above the recommended interim limit.
Class II · Moderate risk
Duloxetine Delayed-Release Capsules
CGMP Deviations: Presence of N-nitroso-duloxetine impurity above the recommended interim limit.
Class II · Moderate risk
Duloxetine Delayed-Release Capsules USP
CGMP Deviations: Presence of N-nitroso-duloxetine impurity above the recommended interim limit.
Class II · Moderate risk
Nebivolol Tablets
CGMP Deviations: Presence of Nitrosamine Drug Substance Related Impurity (NDSRI), N-Nitroso Nebivolol above acceptable intake (AI) limit.
Class II · Moderate risk
Timolol Maleate Ophthalmic Solution USP
Defective Container: Unable to get the solution out of the bottle as the spike of the cap was lodged in the nozzle of the product bottle.
Class II · Moderate risk
Nitrofurantoin Capsules
Failed Dissolution Specifications
Class II · Moderate risk
Duloxetine Delayed-Release Capsules
CGMP Deviations; presence of N-nitroso-duloxetine impurity above recommended interim 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
Cinacalcet Tablets
CGMP deviations: Presence of Nitrosamine Drug Substance Related Impurity (NDSRI), N-Nitroso-Cinacalcet above acceptable intake limit.
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 III · Low risk
Javygtor (sapropterin dihydrochloride)
Failed Impurities/Degradation Specifications
Class II · Moderate risk
10 Irregular Pigmentation
CGMP Deviations: Inconsistency in the water systems.