Duloxetine DR Capsules USP 60 mg, a) 30 count (NDC 57237-019-30) and b) 1000 count (NDC 57237-019-99) bottles; Distributed by: Rising Pharm Holdings, Inc., East Brunswick, NJ
Reason
CGMP Deviations; Presence of N-nitroso-duloxetine impurity above recommended interim limit.
Classification
Class II
Status
Ongoing
Lot
Lot # a) DT6023053A, DT6023061A, DT6023068A, DT6023074A, exp. date Jan-25; DT6023078A, DT6023076A, exp. date Feb-25; DTC24043A, DTC24044A, exp. date Dec-25 b) DT6023002A, DT6023016A, DT6023036A, exp. date Dec-24; DT6023048A, exp. date Jan-25
Date
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