Recall D-0163-2025

US Class II Terminated · initiated 2024-12-04

Recalling firm

PD-Rx Pharmaceuticals, Inc., OK

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

← All recalls