Duloxetine Delayed-Release Capsules USP 30 mg, a) 30 count (NDC 57237-018-30) and b) 1000 count (...
FDA Recall #D-0188-2025 — Class II — December 30, 2024
Product Description
Duloxetine Delayed-Release Capsules USP 30 mg, a) 30 count (NDC 57237-018-30) and b) 1000 count (NDC 57237-018-99) bottles, Rx only, 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
42,527 bottles
Distribution
Nationwide
Code Information
a) Lot# DT3023051A, exp. date Apr-25; b) DT3023025A, exp. date Jan-25
Status
Ongoing
Voluntary / Mandated
Voluntary: Firm initiated