FDAFDA · Food and drugs·Recall number D-0007-2025
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
Published October 9, 2024 · Recall initiated: September 23, 2024
Status when published: Ongoing — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
CGMP deviations
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Advanced Accelerator Applications USA, Inc.
- Distributor
- FL, MA, NJ, NY, PA, and VA
- Lot
- Lot#: LPS240919B-16, 24-Sep-2024 Lot#: LPS240920B-16, 25-Sep-2024 Lot#: LPS240920C-16, 25-Sep-2024
- Risk classification
- Class II
- Area (FDA)
- drug
- Country
- United States
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