Advanced Accelerator Applications recalls Pluvicto injections due to CGMP deviations. Affected lots from September 2024 may pose quality risks. Consumers should contact the manufacturer for details.
CGMP deviations
Advanced Accelerator Applications is recalling Pluvicto injections because of manufacturing quality issues. This recall affects specific lots produced in September 2024. The issue could lead to product quality risks, though serious injuries are not mentioned.
CGMP deviations refer to manufacturing quality issues that could affect the product's safety and effectiveness. These deviations might lead to product quality risks, but the specific nature of the risk is not detailed in the recall notice.
People who have received Pluvicto injections from the specified lots (LPS240919B-16, LPS240920B-16, LPS240920C-16) produced in September 2024 are affected. Patients using this medication for cancer treatment are most at risk.
Check the product label for the lot numbers LPS240919B-16, LPS240920B-16, or LPS240920C-16. The product was manufactured in September 2024 and sold by Advanced Accelerator Applications.
Look for the lot numbers LPS240919B-16, LPS240920B-16, or LPS240920C-16 on the Pluvicto vial.
The recall mentions CGMP deviations, which could affect product quality, but serious injury risks are not specified. The official notice does not state if this poses a health risk.
Contact Advanced Accelerator Applications at 57 E. Willow Street, Millburn, NJ 07041 for details on the recall and next steps.
The affected products were manufactured in September 2024 (lots LPS240919B-16, LPS240920B-16, LPS240920C-16).
We’ve drafted a message you can send Advanced Accelerator Applications to request your refund or repair — edit it as you like.
Subject: Recall D-0007-2025 — Advanced Accelerator Applications Advanced Accelerator Applications Hello, I own a Advanced Accelerator Applications that is covered by recall D-0007-2025 from Advanced Accelerator Applications. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
