Rising Pharma Holding, Inc.: 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,

Hazard

CGMP Deviations; Presence of N-nitroso-duloxetine impurity above recommended interim limit.

Details from the source

Reason for recall: CGMP Deviations; Presence of N-nitroso-duloxetine impurity above recommended interim limit. Distribution: Nationwide Quantity: 244,460 bottles Lot/code info: 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

Source

Official record: FDA (Drug enforcement) ↗

Republished from the official source above; details can change — the source record controls.