Recall archive / FDA drug enforcement
Pluvicto, 1000 MBq/mL (27 mCi/mL), lutetium, LU 177, vipivotide tetraxetan injection, Single-dose vial, Sterile, Manu... — FDA record D-0007-2025
Reported ongoing
Status as reported in the agency record. FDA warns that enforcement status may not track the current recall lifecycle; check the current official notice.
Source date Sep 23, 2024. Retrieved Oct 1, 2026. Last updated Oct 1, 2026.
Archive changed Oct 1, 2026. USDA FSIS records are unavailable; check FSIS directly. Source coverage and dates.
What the record says
- Product
- 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 USA. NDC 69488-0010-61
- Reason
- CGMP deviations
- Classification
- Class II
- Recalling firm
- Advanced Accelerator Applications USA, Inc.
- Quantity
- 99 doses
- Agency-reported status
- Ongoing
- Source record identifier
- D-0007-2025
What the recall classes mean. Classification is an agency assessment, not individual medical advice.
Lot and product identifiers
| Label field | Details supplied by the agency |
|---|---|
| Lot, code or applicability | Lot#: LPS240919B-16, 24-Sep-2024 Lot#: LPS240920B-16, 25-Sep-2024 Lot#: LPS240920C-16, 25-Sep-2024 |
Match all identifying details in the current notice. A brand name alone is not enough.
Distribution
FL, MA, NJ, NY, PA, and VA
States below are derived from the distribution text, including nationwide wording. They are not inferred from the firm's address.
Dates in the source
- Report date
- Oct 9, 2024
- Recall initiation date
- Sep 23, 2024
- Center classification date
- Oct 3, 2024
FDA company pages use the listing date; enforcement records use initiation dates; CPSC uses recall date; NHTSA uses report-received date. These dates are not interchangeable.