Class II
Drug Recall: 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
Advanced Accelerator Applications USA, Inc. · September 23, 2024
Reason for Recall
CGMP deviations
Product Description
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
Distribution
FL, MA, NJ, NY, PA, and VA
States Affected
FL, MA, NJ, NY, PA, VA
Quantity Affected
99 doses
Source: FDA (openFDA Drug Enforcement)
Recall number: D-0007-2025
Status: ongoing
SafeCheck provides drug interaction information from FDA-approved product labeling (openFDA). This is for informational purposes only and is not medical advice. Always consult your healthcare provider before making medication decisions.