FDA recall D-0007-2025

Advanced Accelerator Applications USA, Inc. · Class II · drug

Product

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

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

Key facts

Status: Ongoing
Initiation date: 2024-09-23
Report date: 2024-10-09
Voluntary/Mandated: Voluntary: Firm initiated
Location: Millburn, NJ, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0007-2025