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Advanced Accelerator Applications USA Recalls
4 recalls on record · January 29, 2020 to October 9, 2024 · Drugs
Recalls by year
20
22
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24
Count of recall notices naming this brand, by the year the recall was announced. A quiet year is not proof of a safe year.
October 9, 2024DrugsFDA
Advanced Accelerator Applications USA, Inc. recalls Pluvicto, 1000 MBq/mL (27 mCi/mL), lutetium, LU 177, vipivotide tetraxetan injection, Single-dose vial, Sterile, Manufac
Hazard: CGMP deviations
August 23, 2023DrugsFDA
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, Manufacture
Hazard: Labeling: Incorrect or Missing Lot and/or Exp Date: vials were labeled with the incorrect lot number and expiration date
April 13, 2022DrugsFDA
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 with l
Hazard: Subpotent Drug: low out-of-specification results for Vial 1 assay obtained during stability studies.
January 29, 2020DrugsFDA
Advanced Accelerator Applications USA, Inc. recalls NETSPOT, (kit for the preparation of Ga 68 dotatate injection) 40 mcg dotatate, For Intravenous Use Only, Rx Only, Manuf
Hazard: Defective Container: loose aluminum cap crimp for the dilution buffer vial present in the NETSPOT Kit (vial 2).