Advanced Accelerator Applications USA, Inc. recalls Pluvicto, 1000 MBq/mL (27 mCi/mL), lutetium, LU 177, vipivotide tetraxetan injection, Single-dose vial, Sterile, Manufac
Recalled October 9, 2024 · FDA recall D-0007-2025 · Advanced Accelerator Applications USA
Hazard
CGMP deviations · FDA Class II
Units
99 doses
Sold at
FL, MA, NJ, NY, PA, and VA
Description
CGMP deviations
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
Manufacturer(s)
Advanced Accelerator Applications USA, Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →