Duloxetine DR Capsules USP 60 mg, a) 30 count (NDC 57237-019-30) and b) 1000 count (NDC 57237-01...
FDA Recall #D-0190-2025 — Class II — December 30, 2024
Product Description
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 for Recall
CGMP Deviations; Presence of N-nitroso-duloxetine impurity above recommended interim limit.
Recalling Firm
Rising Pharma Holding, Inc. — East Brunswick, NJ
Classification
Class II — May cause temporary or medically reversible adverse health consequences.
Product Type
Drugs
Product Quantity
244,460 bottles
Distribution
Nationwide
Code Information
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
Status
Ongoing
Voluntary / Mandated
Voluntary: Firm initiated