Advanced Accelerator Applications recalls
FDA enforcement reports naming Advanced Accelerator Applications USA, Inc. as the recalling firm.
- Recall reports
- 4
- Class I (serious)
- 0
- Most recent report
- Oct 9, 2024
- Oct 9, 2024Pluvicto, 1000 MBq/mL (27 mCi/mL), lutetium, LU 177, vipivotide tetraxetan injection, S…Drug · Advanced Accelerator Applications USA, Inc.CGMP deviationsClass II
- Aug 23, 2023PLUVICTO 1,000MBq/mL (27 mCi/mL), lutetium Lu 177 vipivotide tetraxetan injection, 9Drug · Advanced Accelerator Applications USA, Inc.Labeling: Incorrect or Missing Lot and/or Exp Date: vials were labeled with the incorrect lot number and expiration dateClass III
- Apr 13, 2022NETSPOT (kit for the preparation of Ga 68 dotatate injection) 40 mcg dotatate, kit cont…Drug · Advanced Accelerator Applications USA, Inc.Subpotent Drug: low out-of-specification results for Vial 1 assay obtained during stability studies.Class III
- Jan 29, 2020NETSPOT, (kit for the preparation of Ga 68 dotatate injection) 40 mcg dotatate, For Int…Drug · Advanced Accelerator Applications USA, Inc.Defective Container: loose aluminum cap crimp for the dilution buffer vial present in the NETSPOT Kit (vial 2).Class II