PD-Rx Pharmaceuticals, Inc.: Drug Recall
Recall #D-0163-2025 · 12/04/2024
Class II: Risk
Recall Details
- Recall Number
- D-0163-2025
- Classification
- Class II
- Product Type
- Drug
- Recalling Firm
- PD-Rx Pharmaceuticals, Inc.
- Status
- Terminated
- Date Initiated
- 12/04/2024
- Location
- Oklahoma City, OK, United States
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 70, 90-count bottles
Reason for Recall
CGMP Deviations: the presence of a Nitrosamine Drug Substance Related Impurity (NDSRI), N-Nitroso-Duloxetine above the interim acceptable intake limit
Product Description
DULoxetine DR USP, 30 mg, 90-count bottle, Rx Only, Packaged by: PD Rx Pharmaceuticals Inc, Oklahoma City, OK 73127, NDC: 43063-877-90
Distribution Pattern
Distributed within US: FL, MS, WI
Other Recalls by PD-Rx Pharmaceuticals, Inc.
- Class II: Risk 04/06/2023
- Class II: Risk 04/06/2023
- Class II: Risk 04/06/2023
- Class II: Risk 04/06/2023
- Class II: Risk 04/06/2023
Data from FDA openFDA enforcement reports. This site is not affiliated with or endorsed by the FDA. Recall information may be updated by the FDA at any time.