Recall D-0007-2025

US Class II Ongoing · initiated 2024-09-23

Recalling firm

Advanced Accelerator Applications USA, Inc., NJ

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

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