250 recalls · Class II, newest first
Reason CGMP Deviations; Presence of N-nitroso-duloxetine impurity above recommended interim limit.
Reason CGMP Deviations; Presence of N-nitroso-duloxetine impurity above recommended interim limit.
Reason CGMP Deviations; Presence of N-nitroso-duloxetine impurity above recommended interim limit.
Reason Presence of Particulate Matter: A market complaint was received of a glass piece in the vial.
Reason CGMP Deviations; product intended for quarantine was inadvertently distributed
Reason CGMP Deviations
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
Reason Presence of Foreign Tablets/Capsules
Reason CGMP Deviations: Presence of N-nitroso-Dabigatran impurity above recommended interim limit
Reason CGMP Deviations: Presence of N-nitroso-Dabigatran impurity above recommended interim limit
Reason CGMP Deviations: N-Nitroso-Desmethyl Chlorpromazine impurity (NNDCI) were found to be failing per current FDA recommended limit.
Reason CGMP Deviations: N-Nitroso-Desmethyl Chlorpromazine impurity (NNDCI) were found to be failing per current FDA recommended limit.
Reason Crystallization
Reason Crystallization
Reason CGMP Deviations: presence of N-nitroso-duloxetine impurity above FDA recommended interim limit.
Reason CGMP Deviations: presence of N-nitroso-duloxetine impurity above FDA recommended interim limit.
Reason CGMP Deviations: Presence of N-nitroso-duloxetine impurity above the recommended interim limit.
Reason CGMP Deviations: Presence of N-nitroso-duloxetine impurity above the recommended interim limit.
Reason CGMP Deviations: Presence of N-nitroso-duloxetine impurity above the recommended interim limit.
Reason CGMP Deviations: Presence of N-nitroso-duloxetine impurity above the recommended interim limit.
Reason CGMP Deviations: Presence of Nitrosamine Drug Substance Related Impurity (NDSRI), N-Nitroso Nebivolol above acceptable intake (AI) limit.
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.
Reason Failed Dissolution Specifications
Reason CGMP Deviations; presence of N-nitroso-duloxetine impurity above recommended interim limit.
Reason CGMP deviations: Presence of Nitrosamine Drug Substance Related Impurity (NDSRI), N-Nitroso-Cinacalcet above acceptable intake limit.