Advanced Accelerator Applications USA, Inc. has voluntarily recalled 10 units of Pluvicto (lutetium Lu 177 vipivotide tetraxetan) injection. The 9.2 mL single-dose vials were labeled with incorrect lot numbers and expiration dates. This error was discovered during labeling, and the medication was distributed nationwide to hospitals, specialty pharmacies, and cancer treatment centers.
Incorrect lot numbers and expiration dates on vials can lead to the use of medication past its intended shelf life or confusion during administration. No incidents or injuries have been reported to date.
Quantity affected: 10 units
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Sources: FDA iRES · Raw API Response
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