Drug recall
Duloxetine Delayed-Release Cap USP 30mg, 30-count bottle, Rx only, Preferred Pharmaceutcals, Inc., NDC…
FDA recall event 94648 · Class II · Preferred Pharmaceuticals, Inc.
Key facts
| Event ID | 94648 |
|---|---|
| Recall numbers | D-0505-2024 |
| Recalling firm | Preferred Pharmaceuticals, Inc. |
| Product type | Drugs |
| Products | Duloxetine Delayed-Release Cap USP 30mg, 30-count bottle, Rx only, Preferred Pharmaceutcals, Inc., NDC 68788-9301-03 |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary: Firm Initiated |
| Reason for recall | CGMP Deviations: Presence of N-nitroso-duloxetine impurity above FDA recommended interim limit |
| Initiation date | May 10, 2024 |
| Report date | May 29, 2024 |
| City | Anaheim |
| State | CA |
| Country | United States |
| FEI number | 3004582966 |
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: