Advanced Accelerator Applications USA, Inc.
Millburn, NJ, United States
4
Total Recalls
0
Class I Recalls
1
Ongoing Recalls
Recalls by Advanced Accelerator Applications USA, Inc.
FDA Drug
Class II
Ongoing
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, Millbur
September 23, 2024
Advanced Accelerator Applications USA, Inc.
99 doses units
FDA Drug
Class III
Terminated
PLUVICTO 1,000MBq/mL (27 mCi/mL), lutetium Lu 177 vipivotide tetraxetan injection, 9.2 mL Single-dose vial, Manufacturer: Advanced Accelerator Appllications USA, Inc., 57 E. Willow Street NJ 07041, M
August 7, 2023
Advanced Accelerator Applications USA, Inc.
10 units
FDA Drug
Class III
Terminated
NETSPOT (kit for the preparation of Ga 68 dotatate injection) 40 mcg dotatate, kit contains Vial 1 (Reaction vial with lyophilized powder), 1 Single dose vial, consisting of 40 mcg of dotate, 5 mcg of
March 18, 2022
Advanced Accelerator Applications USA, Inc.
14,089 kits units
FDA Drug
Class II
Terminated
NETSPOT, (kit for the preparation of Ga 68 dotatate injection) 40 mcg dotatate, For Intravenous Use Only, Rx Only, Manufactured for: Advanced Accelerator Applications USA, Inc. by Gipharma S.r.l. Stra
January 10, 2020
Advanced Accelerator Applications USA, Inc.
4295 Kits units