Class I · High risk Ongoing
Nhan Sam Tuyet Lien Truy Phong Hoan
Reason Marketed without an Approved NDA/ANDA: FDA analysis found the products to be tainted with undeclared Furosemide, Dexamethasone and Chlorpheniramine
FDA Drug Recalls
2,661 recalls, newest first
Class I · High risk Ongoing
FORCE FOREVER 400mg Tablets
Reason Marketed without an approved NDA/ANDA. FDA analysis found the product to be tainted with Diclofenac and Dexamethasone.
Class II · Moderate risk Ongoing
Dabigatran Etexilate
Reason CGMP Deviations: Presence of N-nitroso-Dabigatran impurity above recommended interim limit
Class II · Moderate risk Ongoing
Dabigatran Etexilate
Reason CGMP Deviations: Presence of N-nitroso-Dabigatran impurity above recommended interim limit
Class II · Moderate risk Ongoing
chlorproMAZINE Hydrochloride Tablets
Reason CGMP Deviations: N-Nitroso-Desmethyl Chlorpromazine impurity (NNDCI) were found to be failing per current FDA recommended limit.
Class II · Moderate risk Ongoing
chlorproMAZINE Hydrochloride Tablets
Reason CGMP Deviations: N-Nitroso-Desmethyl Chlorpromazine impurity (NNDCI) were found to be failing per current FDA recommended limit.
Class II · Moderate risk Ongoing
Dapsone Gel 7.5%
Reason Crystallization
Class II · Moderate risk Ongoing
Dapsone Gel 7.5%
Reason Crystallization
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 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 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