Recall Atlas

Advanced Accelerator Applications recalls

3 official recalls and safety alerts involving Advanced Accelerator Applications since 2022-04, from FDA · Drug. Newest first. Check the official notice for exact models and batch codes.

This list only includes recalls Recall Atlas has collected since 2021-10. A product not listed here may still be affected; check with Advanced Accelerator Applications or the relevant agency.

  1. 2024-10-09
  2. US
    Drugs & medicalClass II

    Advanced Accelerator Applications USA, Inc. recalls Pluvicto, 1000 MBq/mL (27 mCi/mL), lutetium, LU 177, vipivotide tetraxetan injection, Single-dose vial, Sterile,…

    CGMP deviations

    FDA · DrugAdvanced Accelerator Applications USA, Inc.FL, MA, NJ, NY, PA, and VAOfficial notice →
  3. 2023-08-23
  4. US
    Drugs & medicalClass III

    Advanced Accelerator Applications USA, Inc. recalls PLUVICTO 1,000MBq/mL (27 mCi/mL), lutetium Lu 177 vipivotide tetraxetan injection, 9.2 mL Single-dose vial,…

    Labeling: Incorrect or Missing Lot and/or Exp Date: vials were labeled with the incorrect lot number and expiration date

    FDA · DrugAdvanced Accelerator Applications USA, Inc.Distributed Nationwide in the USAOfficial notice →
  5. 2022-04-13
  6. US
    Drugs & medicalClass III

    Advanced Accelerator Applications USA, Inc. recalls NETSPOT (kit for the preparation of Ga 68 dotatate injection) 40 mcg dotatate, kit contains Vial 1 (Reaction vial…

    Subpotent Drug: low out-of-specification results for Vial 1 assay obtained during stability studies.

    FDA · DrugAdvanced Accelerator Applications USA, Inc.Nationwide in the USA and Puerto RicoOfficial notice →