Drug Enforcement D-0188-2025

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

Status

Ongoing

Classification

Class II

Report Date

January 15, 2025

Termination Date

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Product Information

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
Product quantity
42,527 bottles
Reason for recall
CGMP Deviations; Presence of N-nitroso-duloxetine impurity above recommended interim limit.
Recall initiation reason
—
Initial firm notification
Letter
Distribution pattern
Nationwide

Location & Firm

Recalling firm
Rising Pharma Holding, Inc.
Address
2 Tower Center Blvd Ste 1401

United States
Voluntary / Mandated
Voluntary: Firm initiated
Status date
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Codes & Dates

Recall number
D-0188-2025
Event ID
96074
Recall initiation date
December 30, 2024
Center classification date
January 8, 2025
Code info
a) Lot# DT3023051A, exp. date Apr-25; b) DT3023025A, exp. date Jan-25
More code info
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