Class II
Ongoing
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
This recall is currently active, issued October 9, 2024. It was issued by Advanced Accelerator Applications Usa, Inc..
- Recall Initiated
- September 23, 2024
- Posted
- October 9, 2024
- Recall Number
- D-0007-2025
- Voluntary / Mandated
- Voluntary: Firm initiated
- Quantity
- 99 doses
- Firm Location
- Millburn, NJ, United States
- Official Source
- View on FDA website ↗
Reason for Recall
CGMP deviations
Distribution
FL, MA, NJ, NY, PA, and VA
Lot / Code Info
Lot#: LPS240919B-16, 24-Sep-2024 Lot#: LPS240920B-16, 25-Sep-2024 Lot#: LPS240920C-16, 25-Sep-2024
More recalls by Advanced Accelerator Applications Usa, Inc.
PLUVICTO 1,000MBq/mL (27 mCi/mL), lutetium Lu 177 vipivotide tetraxetan injection, 9.2 mL Single-do...
Aug 23, 2023 · Class III
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