Home / Recalls / Advanced Accelerator Applications USA, Inc. / D-0007-2025

D-0007-2025 Class II Ongoing

Recalled by Advanced Accelerator Applications USA, Inc. — Millburn, NJ

Recall Details

Product Type
Drugs
Report Date
October 9, 2024
Initiation Date
September 23, 2024
Termination Date
N/A
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
99 doses

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

Reason for Recall

CGMP deviations

Distribution Pattern

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

Code Information

Lot#: LPS240919B-16, 24-Sep-2024 Lot#: LPS240920B-16, 25-Sep-2024 Lot#: LPS240920C-16, 25-Sep-2024

Other recalls by Advanced Accelerator Applications USA, Inc.

  • D-1085-2023 Class III — PLUVICTO 1,000MBq/mL (27 mCi/mL), lutetium Lu 177 vipivotide tetraxetan injectio (August 7, 2023)
  • D-0747-2022 Class III — NETSPOT (kit for the preparation of Ga 68 dotatate injection) 40 mcg dotatate, k (March 18, 2022)
  • D-0799-2020 Class II — NETSPOT, (kit for the preparation of Ga 68 dotatate injection) 40 mcg dotatate, (January 10, 2020)