15 recalls on record
CGMP Deviations; presence of N-nitroso-duloxetine impurity above the FDA recommended limit
CGMP Deviations; presence of N-nitroso-duloxetine impurity above the FDA recommended limit
CGMP Deviations: N-nitroso-duloxetine impurity above the safety assessment limit of 12.5ppm.
CGMP deviations: N-nitroso-duloxetine impurity above the proposed interim limit.
CGMP Deviations: Presence of N-nitroso-duloxetine impurity above FDA recommended interim limit.
CGMP Deviations: Presence of N-nitroso-duloxetine impurity above safety assessment limit
CGMP Deviations: Presence of N-nitroso-duloxetine impurity above FDA recommended interim limit
CGMP Deviations: Presence of Nitrosamine Drug Substance Related Impurity above the proposed interim limit.
CGMP Deviations: Presence of Nitrosamine Drug Substance Related Impurity above the proposed interim limit.
CGMP Deviations: presence of Nitrosamine Drug Substance Related Impurity (NDSRI), N-nitroso-duloxetine, above the recommended interim limit.
CGMP Deviations: Presence of N-nitroso-duloxetine impurity above FDA recommended interim limit.
CGMP Deviations: Presence of N-nitroso-duloxetine impurity above FDA recommended interim limit.
CGMP Deviations: Presence of N-nitroso-duloxetine impurity above FDA recommended interim limit.
CGMP Deviations: presence of N-nitroso-duloxetine impurity above FDA recommended interim limit.
CGMP Deviations: presence of N-nitroso-duloxetine impurity above FDA recommended interim limit.