Advanced Accelerator Applications USA, Inc.: Drug Recall

Recall #D-0007-2025 · 09/23/2024

Class II: Risk

Recall Details

Recall Number: D-0007-2025
Classification: Class II
Product Type: Drug
Recalling Firm: Advanced Accelerator Applications USA, Inc.
Status: Ongoing
Date Initiated: 09/23/2024
Location: Millburn, NJ, United States
Voluntary/Mandated: Voluntary: Firm initiated
Product Quantity: 99 doses

Reason for Recall

CGMP deviations

Product Description

Pluvicto, 1000 MBq/mL (27 mCi/mL), lutetium, LU 177, vipivotide tetraxetan injection, Single-dose vial, Sterile, Manufacturer Advanced Accelerator Applications, 57 E. Willow Street, NJ 07041, Millburn USA. NDC 69488-0010-61

Distribution Pattern

FL, MA, NJ, NY, PA, and VA

Other Recalls by Advanced Accelerator Applications USA, Inc.

Class III: Low Risk 08/07/2023

Labeling: Incorrect or Missing Lot and/or Exp Date: vials were labeled with the incorrect lot number and expiration date
Class III: Low Risk 03/18/2022

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

View all recalls by Advanced Accelerator Applications USA, Inc. →

Data from FDA openFDA enforcement reports. This site is not affiliated with or endorsed by the FDA. Recall information may be updated by the FDA at any time.