- 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
- Recalling company
- Advanced Accelerator Applications USA, Inc.
- Classification
- Class II
- Status
- Ongoing
- Type
- Voluntary: Firm initiated
- Distribution
- FL, MA, NJ, NY, PA, and VA
- Initiated
- Sep 23, 2024
- FDA report date
- Oct 9, 2024