Drug Enforcement D-0163-2025

CGMP Deviations: the presence of a Nitrosamine Drug Substance Related Impurity (NDSRI), N-Nitroso-Duloxetine above the interim acceptable intake limit

Status

Terminated

Classification

Class II

Report Date

January 1, 2025

Termination Date

March 21, 2025

Product Information

Product description
DULoxetine DR USP, 30 mg, 90-count bottle, Rx Only, Packaged by: PD Rx Pharmaceuticals Inc, Oklahoma City, OK 73127, NDC: 43063-877-90
Product quantity
70, 90-count bottles
Reason for recall
CGMP Deviations: the presence of a Nitrosamine Drug Substance Related Impurity (NDSRI), N-Nitroso-Duloxetine above the interim acceptable intake limit
Recall initiation reason
—
Initial firm notification
E-Mail
Distribution pattern
Distributed within US: FL, MS, WI

Location & Firm

Recalling firm
PD-Rx Pharmaceuticals, Inc.
Address
727 N Ann Arbor Ave

United States
Voluntary / Mandated
Voluntary: Firm initiated
Status date
—

Codes & Dates

Recall number
D-0163-2025
Event ID
95922
Recall initiation date
December 4, 2024
Center classification date
December 23, 2024
Code info
Lot # I24E77, A24E49, Exp Date: 04/30/25; J23C50, J23C97, L23B39, L23E98, Exp Date: 01/31/2025
More code info
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