Class II · Moderate risk Ongoing
Dapsone Gel 7.5%
Reason Crystallization
FDA Drug Recalls
14,450 recalls · Class II, newest first
Class II · Moderate risk Ongoing
Dapsone Gel 7.5%
Reason Crystallization
Class II · Moderate risk Terminated
PROFESSIONAL Regener-Eyes
Reason Lack of Sterility Assurance
Class II · Moderate risk Terminated
LITE Regener-Eyes
Reason Lack of Sterility Assurance
Class II · Moderate risk Ongoing
Duloxetine Delayed-Release Capsules
Reason CGMP Deviations: presence of N-nitroso-duloxetine impurity above FDA recommended interim limit.
Class II · Moderate risk Ongoing
Duloxetine Delayed-Release Capsules
Reason CGMP Deviations: presence of N-nitroso-duloxetine impurity above FDA recommended interim limit.
Class II · Moderate risk Ongoing
Duloxetine Delayed-Release Capsules
Reason CGMP Deviations: Presence of N-nitroso-duloxetine impurity above the recommended interim limit.
Class II · Moderate risk Ongoing
Duloxetine Delayed-Release Capsules USP
Reason CGMP Deviations: Presence of N-nitroso-duloxetine impurity above the recommended interim limit.
Class II · Moderate risk Ongoing
Duloxetine Delayed-Release Capsules
Reason CGMP Deviations: Presence of N-nitroso-duloxetine impurity above the recommended interim limit.
Class II · Moderate risk Ongoing
Duloxetine Delayed-Release Capsules USP
Reason CGMP Deviations: Presence of N-nitroso-duloxetine impurity above the recommended interim limit.
Class II · Moderate risk Ongoing
Nebivolol Tablets
Reason CGMP Deviations: Presence of Nitrosamine Drug Substance Related Impurity (NDSRI), N-Nitroso Nebivolol above acceptable intake (AI) limit.
Class II · Moderate risk Ongoing
Timolol Maleate Ophthalmic Solution USP
Reason 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 Ongoing
Nitrofurantoin Capsules
Reason Failed Dissolution Specifications
Class II · Moderate risk Terminated
DULoxetine DR USP
Reason CGMP Deviations: the presence of a Nitrosamine Drug Substance Related Impurity (NDSRI), N-Nitroso-Duloxetine above the interim acceptable intake limit
Class II · Moderate risk Ongoing
Duloxetine Delayed-Release Capsules
Reason CGMP Deviations; presence of N-nitroso-duloxetine impurity above recommended interim limit.
Class II · Moderate risk Ongoing
Cinacalcet Tablets
Reason CGMP deviations: Presence of Nitrosamine Drug Substance Related Impurity (NDSRI), N-Nitroso-Cinacalcet above acceptable intake limit.
Class II · Moderate risk Ongoing
Cinacalcet Tablets
Reason CGMP deviations: Presence of Nitrosamine Drug Substance Related Impurity (NDSRI), N-Nitroso-Cinacalcet above acceptable intake limit.
Class II · Moderate risk Ongoing
Cinacalcet Tablets
Reason CGMP deviations: Presence of Nitrosamine Drug Substance Related Impurity (NDSRI), N-Nitroso-Cinacalcet above acceptable intake limit.
Class II · Moderate risk Terminated
Kit for the Preparation of Technetium Tc 99m Sestamibi Injection
Reason Lack of Assurance of Sterility; Improper crimps on vials impacting the integrity of the product
Class II · Moderate risk Ongoing
Olanzapine Tablets
Reason Failed Impurities/Degradation Specifications
Class II · Moderate risk Ongoing
Kit for the Preparation of Technetium Tc 99m Sulfur Colloid Injection
Reason Failed Stability Specifications
Class II · Moderate risk Ongoing
VCF, Vaginal Contraceptive Gel
Reason CGMP deviations: out of specifications for assay
Class II · Moderate risk Ongoing
Dihydroergotamine Mesylate Injection
Reason Discoloration
Class II · Moderate risk Ongoing
10 Irregular Pigmentation
Reason CGMP Deviations: Inconsistency in the water systems.
Class II · Moderate risk Ongoing
Levothyroxine Sodium Tablets
Reason Subpotent and Superpotent Drug