Drug recall
Pluvicto, 1000 MBq/mL (27 mCi/mL), lutetium, LU 177, vipivotide tetraxetan injection, Single-dose vial…
FDA recall event 95420 · Class II · Advanced Accelerator Applications USA, Inc.
Key facts
| Event ID | 95420 |
|---|---|
| Recall numbers | D-0007-2025 |
| Recalling firm | Advanced Accelerator Applications USA, Inc. |
| Product type | Drugs |
| Products | Pluvicto, 1000 MBq/mL (27 mCi/mL), lutetium, LU 177, vipivotide tetraxetan injection, Single-dose vial, Sterile, Manufacturer Advanced Accelerator Applications, 57 E. Willow Street, NJ 07041, Millburn… |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary: Firm Initiated |
| Reason for recall | CGMP deviations |
| Initiation date | Sep 23, 2024 |
| Report date | Oct 9, 2024 |
| City | Millburn |
| State | NJ |
| Country | United States |
| FEI number | 3012484129 |
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: