Pluvicto Radiopharmaceutical Drug Recalled Due to Manufacturing Quality Deviations
Advanced Accelerator Applications is recalling 99 doses of Pluvicto (lutetium LU-177 injection) due to manufacturing quality deviations. The affected lots were distributed to six states.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: This is a Class II drug recall involving manufacturing quality deviations in a radiopharmaceutical, which constitutes a risk-of-harm product. No reported illnesses or injuries and no specific hazard details are stated in the source, placing this at Score 3 per the rubric criterion for risk-of-harm products where injury has not yet been reported.
Plain-English summary
Advanced Accelerator Applications USA, Inc. is recalling 99 doses of Pluvicto (lutetium LU-177 vipivotide tetraxetan injection) due to manufacturing quality control deviations discovered in the production process.
Three lots are affected: LPS240919B-16 (manufactured 24 September 2024), LPS240920B-16 (25 September 2024), and LPS240920C-16 (25 September 2024). These single-dose vials containing 1000 MBq/mL (27 mCi/mL) were distributed to healthcare facilities in Florida, Massachusetts, New Jersey, New York, Pennsylvania, and Virginia.
The firm initiated this voluntary recall on 23 September 2024 after discovering the manufacturing quality issues. The FDA classified this as a Class II recall on 3 October 2024, and the recall status remains ongoing.
No illnesses or injuries have been reported associated with this recall. Healthcare providers with affected product should contact Advanced Accelerator Applications for instructions regarding the recalled doses.
The recalled product
- Product
- 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
- Manufacturer
- Advanced Accelerator Applications USA, Inc.
- Category
- Drug — Radiopharmaceutical
- Hazard
- manufacturing-quality-deviation
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (4)
- Lot#: LPS240919B-16
- 24-Sep-2024 Lot#: LPS240920B-16
- 25-Sep-2024 Lot#: LPS240920C-16
- 25-Sep-2024
Distribution
Distributed in 6 states:
- FL
- MA
- NJ
- NY
- PA
- VA
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