FDA-Drug2024-10-09Class II
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
Advanced Accelerator Applications USA, Inc.
Hazard
CGMP deviations
Sold states
FL, MA, NJ, NY, PA, and VA
Affected count
99 doses
Manufactured in
57 E Willow St, N/A, Millburn, NJ, United States
Products
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
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0007-2025Don't want to check this manually?
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