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FDASeptember 23, 2024drug

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

Official recall recorded by the U.S. Food & Drug Administration.

The hazard

CGMP deviations

What to do

FDA enforcement status: Ongoing

Brands named

advanced accelerator applicationsadvancedadvanced accelerator

UPCs

69488001061

Recall history

Other federal recalls tied to the same brand — a factual pattern, straight from the source data.

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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 — Recall Details · AllClear