Class IIReported 2025-01-15

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

Recalled by Rising Pharma Holding, Inc.

Reason for Recall

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

Recall Number

D-0190-2025

Classification

Class II

Status

Ongoing

Category

drug

Initiated

2024-12-30

Reported

2025-01-15

Distribution

Nationwide

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: openFDA enforcement report. WhichRecall is not affiliated with the FDA. See our disclaimer.