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Advanced Accelerator Applications USA, Inc. FDA Recalls
3 recalls on file across drugs, 0 of them Class I and 1 still open. This firm is not matched to a listed company.
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Class I is the FDA's most serious grade: a reasonable probability of serious harm or death.
| Product |
|---|
| Pluvicto, 1000 MBq/mL (27 mCi/mL), lutetium, LU 177, vipivotide tetraxetan injection, Single-dose vial, Sterile, ManufacClass IISep 23, 2024CGMP deviations |
| PLUVICTO 1,000MBq/mL (27 mCi/mL), lutetium Lu 177 vipivotide tetraxetan injection, 9.2 mL Single-dose vial, ManufactureClass IIIAug 7, 2023Labeling: Incorrect or Missing Lot and/or Exp Date: vials we |
| NETSPOT (kit for the preparation of Ga 68 dotatate injection) 40 mcg dotatate, kit contains Vial 1 (Reaction vial with lClass IIIMar 18, 2022Subpotent Drug: low out-of-specification results for Vial 1 |