Advanced Accelerator Applications USA, Inc. Provisional
FDA Flags (3)
Class II RecallOct 2024
Advanced Accelerator Applications USA, Inc.
Pluvicto, 1000 MBq/mL (27 mCi/mL), lutetium, LU 177, vipivotide tetraxetan injection, Single-dose vial, Sterile, Manufac
Classification: Class II
Class III RecallAug 2023
Advanced Accelerator Applications USA, Inc.
PLUVICTO 1,000MBq/mL (27 mCi/mL), lutetium Lu 177 vipivotide tetraxetan injection, 9.2 mL Single-dose vial, Manufacture
Classification: Class III
Class III RecallApr 2022
Advanced Accelerator Applications USA, Inc.
NETSPOT (kit for the preparation of Ga 68 dotatate injection) 40 mcg dotatate, kit contains Vial 1 (Reaction vial with l
Classification: Class III