Drug product

DULoxetine DR USP, 30 mg, 90-count bottle, Rx Only, Packaged by: PD Rx Pharmaceuticals Inc, Oklahoma City, OK 73127, NDC: 43063-877-90

D-0163-2025

December 04, 2024

Class II

Product summary

Firm: PD-Rx Pharmaceuticals, Inc.
Event: Event 95922
Status: Terminated
Classification: Class II
Quantity: 70, 90-count bottles
Official record key: drug-enforcement:D-0163-2025

Official wording

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

Code information: Lot # I24E77, A24E49, Exp Date: 04/30/25; J23C50, J23C97, L23B39, L23E98, Exp Date: 01/31/2025

Distribution pattern: Distributed within US: FL, MS, WI

Derived failure modes

Foreign material or chemical contamination
reason.foreign_material_chemical_contamination · v1.0.0

Nitrosamine Drug Substance Related Impurity
Manufacturing or process control
reason.manufacturing_process_control · v1.0.0

CGMP Deviations