Recalls / Class II

Class IID-0007-2025

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

Affected lot / code info

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

Why it was recalled

CGMP deviations

Recalling firm

Firm

Advanced Accelerator Applications USA, Inc.

Notification channel

Letter

Type

Voluntary: Firm initiated

Address

57 E Willow St, N/A, Millburn, New Jersey 07041-1416

Distribution

Quantity

99 doses

Distribution pattern

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

Timeline

Recall initiated

2024-09-23

FDA classified

2024-10-03

Posted by FDA

2024-10-09

Status

Ongoing

Source: openFDA Drug Enforcement endpoint. Recall record D-0007-2025. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.