Advanced Accelerator Applications USA, Inc. is recalling 99 doses of Pluvicto (lutetium Lu 177 vipivotide tetraxetan) injection, a sterile medication provided in single-dose vials. The recall was initiated due to deviations from Current Good Manufacturing Practice (CGMP) standards during production. This voluntary recall affects specific lots distributed to healthcare facilities in six states in September 2024.
Deviations in manufacturing standards mean the product may not meet strict quality and safety requirements for sterile injectable drugs. If you have concerns about treatment you received, contact your healthcare provider or pharmacist.
Quantity: 99 doses
If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.
This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.
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Sources: FDA iRES · Raw API Response
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