Duloxetine DR Capsules USP 60 mg, a) 30 count (NDC 57237-019-30) and b) 1000 count (NDC 57237-019-99) bottles; Distributed by…
Reason CGMP Deviations; Presence of N-nitroso-duloxetine impurity above recommended interim limit.
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 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 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: the presence of a Nitrosamine Drug Substance Related Impurity (NDSRI), N-Nitroso-Duloxetine above the interim acceptable intake 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 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 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 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 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 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: Lack of stability data and controls to support the manufacturers assigned retest or expiration date in firm's container/closure…
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