FDA Drugs recall ·
Pluvicto, 1000 MBq/mL (27 mCi/mL), lutetium, LU 177… recall
- Recall number
- D-0007-2025
- Date
- (initiated September 23, 2024)
- Company / brand
- Advanced Accelerator Applications USA, Inc.
57 E Willow St, Millburn, NJ, United States - Category
- Drugs › Class II
- Classification
- Class II
- Status
- Ongoing
- Units affected
- 99 doses
- Hazard tags
- Manufacturing practices (cGMP)
- Initiated by
- Voluntary: Firm initiated
Read the official FDA notice ↗
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
Why was it recalled?
CGMP deviations
What should you do?
FDA enforcement reports do not list a consumer remedy. Check the product codes below against what you have; if it matches, stop using it and follow the instructions in the firm's or FDA's official notice, or contact the company. If you have health concerns, contact your healthcare provider.
Product codes & lot numbers
Lot#: LPS240919B-16, 24-Sep-2024 Lot#: LPS240920B-16, 25-Sep-2024 Lot#: LPS240920C-16, 25-Sep-2024
Distribution
FL, MA, NJ, NY, PA, and VA
States: Florida Massachusetts New Jersey New York Pennsylvania Virginia
What does Class II mean?
Class II means use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or the probability of serious harm is remote.
Source: FDA (drugs), recall D-0007-2025. Official notice. Republished from public data; RecallFlag is not affiliated with the FDA.