FDAHealthSeptember 23, 2024
Advanced Accelerator Applications USA, Inc. — Pluvicto, 1000 MBq/mL (27 mCi/mL), lutetium, LU 177, vipivotide tetraxetan injection, Single-dose vial, Sterile, Manufacturer Advanced Accelerator Applica
⚠️ CGMP deviations
Is this relevant to me?
- Geography
- FL, MA, NJ, NY, PA, VA
- Source agency
- FDA
- Category
- Health
- Published
- September 23, 2024
FL, MA, NJ, NY, PA, and VA
What's affected?
- 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
- Lot code
- LPS240919B-16
Additional details
Lot#: LPS240919B-16, 24-Sep-2024 Lot#: LPS240920B-16, 25-Sep-2024 Lot#: LPS240920C-16, 25-Sep-2024
What should I do?
Recommended action
Class II recall. Voluntary: Firm initiated Quantity affected: 99 doses.
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