FDA recall D-0163-2025

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

Distribution

Distributed within US: FL, MS, WI

Key facts

Status

Terminated

Initiation date

2024-12-04

Report date

2025-01-01

Termination date

2025-03-21

Voluntary/Mandated

Voluntary: Firm initiated

Location

Oklahoma City, OK, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0163-2025