FDA Recall D-0007-2025
Advanced Accelerator Applications USA, Inc. · Millburn, NJ
Class II Ongoing 598 days on record
Moderate impact — Class II recall — temporary or medically reversible adverse health consequence possible; remote probability of serious adverse health consequence.
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
Reason for recall
CGMP deviations
Recall record
- Recall number
D-0007-2025- Classification
- Class II
- Status
- Ongoing
- Voluntary or mandated
- Voluntary: Firm initiated
- Firm notification
- Letter
- Distribution
- FL, MA, NJ, NY, PA, and VA
- Recall initiated
- 2024-09-23
- Classified by FDA Center
- 2024-10-03
- FDA published
- 2024-10-09
- Recalling firm
- Advanced Accelerator Applications USA, Inc.
- Firm location
- Millburn, NJ
Operational response
Class II recalls indicate possible temporary or reversible health consequences. Remove affected lots from active dispensing. Segregate inventory. Check the firm’s recall notification for guidance on patient outreach.
For the official FDA enforcement record, see FDA's Recall Search.