Drug recall
DULoxetine DR USP, 30 mg, 90-count bottle, Rx Only, Packaged by: PD Rx Pharmaceuticals Inc, Oklahoma City, OK…
FDA recall event 95922 · Class II · PD-Rx Pharmaceuticals, Inc.
Key facts
| Event ID | 95922 |
|---|---|
| Recall numbers | D-0163-2025 |
| Recalling firm | PD-Rx Pharmaceuticals, Inc. |
| Product type | Drugs |
| Products | DULoxetine DR USP, 30 mg, 90-count bottle, Rx Only, Packaged by: PD Rx Pharmaceuticals Inc, Oklahoma City, OK 73127, NDC: 43063-877-90 |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary: Firm Initiated |
| Reason for recall | CGMP Deviations: the presence of a Nitrosamine Drug Substance Related Impurity (NDSRI), N-Nitroso-Duloxetine above the interim acceptable intake limit |
| Initiation date | Dec 4, 2024 |
| Report date | Jan 1, 2025 |
| Termination date | Mar 21, 2025 |
| City | Oklahoma City |
| State | OK |
| Country | United States |
| FEI number | 1641825 |
At a glance
- 1–9 Products in this recall
- 1–9 FDA inspections of this firm (FEI)
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA drug and product recalls
FDA enforcement reports list recalls of drugs, biologics, foods and other FDA-regulated products, classified by the potential health hazard.
Source: U.S. Food and Drug Administration (FDA), Enforcement Reports · Source date: