DULOXETINE (DULOXETINE HYDROCHLORIDE)
Wed Jan 01 2025
1 of 12
Summary
CGMP Deviations: the presence of a Nitrosamine Drug Substance Related Impurity (NDSRI), N-Nitroso-Duloxetine above the interim acceptable intake limit
Product Description
| Drug | Manufacturer | Distribution Pattern | Number of Affected Units |
|---|---|---|---|
| DULoxetine DR USP, 30 mg, 90-count bottle, Rx Only, Packaged by: PD Rx Pharmaceuticals Inc, Oklahoma City, OK 73127, NDC: 43063-877-90 | PD-Rx Pharmaceuticals, Inc. | Distributed within US: FL, MS, WI | 70, 90-count bottles |