Duloxetine D/R, 20 mg, 30 Caps, 30-count bottle, RX Only, Packaged & Distributed by: Direct Rx, Dist. By Breckenridge Pharm…
Reason CGMP Deviations: Presence of Nitrosamine Drug Substance Related Impurity above the proposed interim limit.
Recalls of antidepressants, anti-anxiety and related psychiatric medications.
226 recalls in this category, newest first.
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 Failed Tablet/Capsule Specifications: Missing tab ID on either side of the tablet
Reason CGMP Deviations: presence of Nitrosamine Drug Substances Related Impurity (NDSRI), N-Nitroso-Duloxetine above the FDA recommended acceptable intake…
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 Labeling: Label Error on Declared Strength; Some cartons were incorrectly labeled. The blister strips inside the product carton reflect the correct…
Reason Labeling: Label Error on Declared Strength; Some cartons were incorrectly labeled. The blister strips inside the product carton reflect the correct…
Reason Labeling: Label Error on Declared Strength; Some cartons were incorrectly labeled. The blister strips inside the product carton reflect the correct…
Reason Labeling: Label Error on Declared Strength; Some cartons were incorrectly labeled. The blister strips inside the product carton reflect the correct…
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