Reported Oct 9, 2024 · Ongoing
Pluvicto, 1000 MBq/mL (27 mCi/mL), lutetium, LU 177, vipivotide tetraxetan injection, Single-dose vial, Sterile,…
Advanced Accelerator Applications USA, Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Advanced Accelerator Applications USA, Inc. · 57 E Willow St · Millburn, NJ · 07041-1416
Is this the product you have?
- 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 codes and dates
Lot#: LPS240919B-1624-Sep-2024 Lot#: LPS240920B-1625-Sep-2024 Lot#: LPS240920C-1625-Sep-2024
- Amount recalled
- 99 doses
Where it was sold
Why it was recalled
CGMP deviations
This product could cause temporary or reversible health problems — stop using it.
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