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Advanced Accelerator Applications USA, Inc.

Advanced Accelerator Applications USA, Inc. Recalls

All product recalls associated with Advanced Accelerator Applications USA, Inc..

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Recall Summary

Total Recalls

Past Year

Class I (Serious)

Most Recent

Sep 2024

Data from FDA, USDA, CPSC, and NHTSA public records. Recall counts vary by company size, industry, and reporting practices. Always check official sources for current information.

Showing 1–4 of 4 recalls

Pluvicto Injection (Advanced Accelerator) – Manufacturing Deviations (2024)

CGMP deviations

Class IIModerate

FDASep 23, 2024FL, MA, NJ +3 more• Advanced Accelerator Applications USA, Inc.

Pluvicto (Advanced Accelerator) – Incorrect Labeling (2023)

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

Class IIILow

FDAAug 7, 2023Nationwide• Advanced Accelerator Applications USA, Inc.

NETSPOT Dotatate Kit (Advanced Accelerator) – Subpotent Drug (2022)

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

Class III

Low

FDAMar 18, 2022Nationwide• Advanced Accelerator Applications USA, Inc.

NETSPOT (Advanced Accelerator Applications) – Defective Container Cap (2020)

Defective Container: loose aluminum cap crimp for the dilution buffer vial present in the NETSPOT Kit (vial 2).

Class IIModerate

FDAJan 10, 2020Nationwide• Advanced Accelerator Applications USA, Inc.