Duloxetine Delayed-Release Capsules USP 20 mg, 60 count bottles, Rx only, Distributed by: Rising ...
FDA Recall #D-0189-2025 — Class II — December 30, 2024
Product Description
Duloxetine Delayed-Release Capsules USP 20 mg, 60 count bottles, Rx only, Distributed by: Rising Pharm Holdings, Inc., East Brunswick, NJ NDC 57237-017-60
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
73,680 bottles
Distribution
Nationwide
Code Information
Lot # DT2023003A, DT2023007A, DT2023008A, exp. date Jan-25
Status
Ongoing
Voluntary / Mandated
Voluntary: Firm initiated