Pluvicto recalled over manufacturing violations
- Recall date
- September 23, 2024
- Source
- U.S. Food & Drug Administration (FDA) — enforcement report
- Official notice title
- Advanced Accelerator Applications USA, Inc. recalls Pluvicto, 1000 MBq/mL (27 mCi/mL), lutetium, LU 177, vipivotide tetraxetan injection, Single-dose vial, Sterile, Manufa…
- Recall number
- D-0007-2025
- FDA classification
- Class II
- Brand / firm
- Advanced Accelerator Applications USA, Inc.
- Sold / distributed
- FL, MA, NJ, NY, PA, and VA
Why it was recalled
CGMP deviations
Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.
What was recalled
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
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