Class II
Terminated
DULoxetine DR USP, 30 mg, 90-count bottle, Rx Only, Packaged by: PD Rx Pharmaceuticals Inc, Oklahoma City, OK 73127, NDC: 43063-877-90
- Company
- Pd-Rx Pharmaceuticals, Inc.
- Recall Initiated
- December 4, 2024
- Posted
- January 1, 2025
- Recall Number
- D-0163-2025
- Voluntary / Mandated
- Voluntary: Firm initiated
- Quantity
- 70, 90-count bottles
- Firm Location
- Oklahoma City, OK, United States
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
Lot / Code Info
Lot # I24E77, A24E49, Exp Date: 04/30/25; J23C50, J23C97, L23B39, L23E98, Exp Date: 01/31/2025
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