Drug recall D-0163-2025

Class II Terminated reported Jan 1, 2025

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

Reason for recall

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

Lots and codes

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

Recall details

Recalling firm
PD-Rx Pharmaceuticals, Inc., Oklahoma City, OK
Quantity
70, 90-count bottles
Distribution
Distributed within US: FL, MS, WI
Type
Voluntary: Firm initiated
Recall initiated
December 4, 2024
Terminated
March 21, 2025