63 FDA recalls mention Duloxetine. The most recent are listed below.
Recalls are matched by product description. A recall usually affects specific lots, not every package of Duloxetine.
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 FDA recommended interim limit
Reason CGMP Deviations; presence of Nitrosamine Drug Substance Related Impurity (NDSRI), N-nitroso-duloxetine, above the FDA acceptable intake limit.
Reason CGMP Deviations: Presence of N-nitroso-Duloxetine impurity above FDA recommended limit of 0.83 ppm, identified at the 12-month and 18-month long-term…
Reason CGMP Deviations: Presence of N-nitroso-Duloxetine impurity above FDA recommended limit of 0.83 ppm, identified at the 12-month and 18-month long-term…
Reason CGMP Deviations: Presence of N-nitroso-Duloxetine impurity above FDA recommended limit of 0.83 ppm, identified at the 12-month and 18-month long-term…
Reason CGMP Deviations; presence of N-nitroso-duloxetine impurity above the FDA recommended limit
Reason CGMP Deviations; presence of N-nitroso-duloxetine impurity above the FDA recommended limit
Reason CGMP Deviations; presence of N-nitroso-duloxetine impurity above the FDA recommended limit
Reason CGMP Deviations: N-nitroso-duloxetine impurity above the safety assessment limit of 12.5ppm.
Reason CGMP deviations: N-nitroso-duloxetine impurity above the proposed 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 safety assessment limit
Reason CGMP Deviations: Presence of N-nitroso-duloxetine impurity above FDA recommended interim limit
Reason CGMP Deviations: Presence of Nitrosamine Drug Substance Related Impurity above the proposed interim limit.
Reason CGMP Deviations: Presence of Nitrosamine Drug Substance Related Impurity above the proposed interim limit.
Reason CGMP Deviations: presence of Nitrosamine Drug Substance Related Impurity (NDSRI), N-nitroso-duloxetine, above the recommended interim limit.
Reason CGMP Deviations: Presence of Nitrosamine Drug Substance Related Impurity above the proposed interim limit.
Reason CGMP Deviations: Presence of Nitrosamine Drug Substance Related Impurity above the proposed 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 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 FDA recommended interim limit.
Reason CGMP Deviations: presence of Nitrosamine Drug Substances Related Impurity (NDSRI), N-Nitroso-Duloxetine above the FDA recommended acceptable intake…
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