FDA DrugClass IINotable
FDA Recall: DULOXETINE D/R, a) 30 mg (NDC 61919-482-30), 30 Caps; b) 30 mg (NDC 61919-482-60), 60 Caps; CYMBALTA
Description
CGMP Deviations: Presence of N-nitroso-duloxetine impurity above FDA recommended interim limit
Hazard
CGMP Deviations: Presence of N-nitroso-duloxetine impurity above FDA recommended interim limit
Remedy
263 Bottles
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