Drug 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
D-0007-2025
Product summary
- Event
- Event 95420
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 99 doses
- Official record key
drug-enforcement:D-0007-2025
Official wording
Reason: CGMP deviations
Code information: Lot#: LPS240919B-16, 24-Sep-2024 Lot#: LPS240920B-16, 25-Sep-2024 Lot#: LPS240920C-16, 25-Sep-2024
Distribution pattern: FL, MA, NJ, NY, PA, and VA
Derived failure modes
-
Manufacturing or process control
CGMP deviations