Class II · Moderate risk Ongoing
Carvedilol Tablets
Reason CGMP Deviations:N-Nitroso Carvedilol I impurity (NNCI-I) were found to be failing per current FDA recommended limit.
FDA Drug Recalls
2,277 recalls · Class II, newest first
Class II · Moderate risk Ongoing
Lorazepam Tablets
Reason Failed impurities/degradation specifications and Sub-potent Drug: Out-of-specification results were obtained during routine stability testing for Assay and Impurities.
Class II · Moderate risk Ongoing
Lorazepam Tablets
Reason Failed impurities/degradation specifications and Sub-potent Drug: Out-of-specification results were obtained during routine stability testing for Assay and Impurities.
Class II · Moderate risk Ongoing
Lorazepam Tablets
Reason Failed impurities/degradation specifications and Sub-potent Drug: Out-of-specification results were obtained during routine stability testing for Assay and Impurities.
Class II · Moderate risk Ongoing
Irbesartan Tablets USP
Reason Out of Specification for Dissolution
Class II · Moderate risk Ongoing
Inflectra
Reason cGMP Deviations: Product intended for quarantine was inadvertently distributed.
Class II · Moderate risk Ongoing
Granix
Reason Failed Stability Specifications - 12-month stability test result for one of the known peptides is below the specification limit
Class II · Moderate risk Ongoing
babyganics
Reason Failed stability specifications: during routine stability monitoring quality concerns were identified. Physical separation for ingredients was observed.
Class II · Moderate risk Ongoing
Clobazam Tablets
Reason Presence of Foreign Tablets/Capsules
Class II · Moderate risk Ongoing
Duloxetine DR Capsules USP 60 mg
Reason CGMP Deviations; Presence of N-nitroso-duloxetine impurity above recommended interim limit.
Class II · Moderate risk Ongoing
Duloxetine Delayed-Release Capsules USP 20 mg
Reason CGMP Deviations; Presence of N-nitroso-duloxetine impurity above recommended interim limit.
Class II · Moderate risk Ongoing
Duloxetine Delayed-Release Capsules USP 30 mg
Reason CGMP Deviations; Presence of N-nitroso-duloxetine impurity above recommended interim limit.
Class II · Moderate risk Ongoing
Progesterone Injection USP
Reason Presence of Particulate Matter: A market complaint was received of a glass piece in the vial.
Class II · Moderate risk Ongoing
First Aid Beauty Ultra Repair Cream
Reason CGMP Deviations; product intended for quarantine was inadvertently distributed
Class II · Moderate risk Ongoing
medroxyPROGESTERone Acetate Injectable Suspension
Reason CGMP Deviations
Class II · Moderate risk Ongoing
Ciprofloxacin 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
Clobazam Tablets
Reason Presence of Foreign Tablets/Capsules
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.