Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
Pluvicto Recalled by Advanced Accelerator Applications USA, Inc. Due to CGMP deviations
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact Advanced Accelerator Applications USA, Inc. directly.
Affected Products
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
Quantity: 99 doses
Why Was This Recalled?
CGMP deviations
Where Was This Sold?
This product was distributed to 6 states: FL, MA, NJ, NY, PA, VA
About Advanced Accelerator Applications USA, Inc.
Advanced Accelerator Applications USA, Inc. has 4 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Drug). Last updated March 26, 2026. View original report