Why it was recalled
CGMP deviations
Product description
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
Lot numbers, UPCs & expiration codes
Lot#: LPS240919B-16, 24-Sep-2024 Lot#: LPS240920B-16, 25-Sep-2024 Lot#: LPS240920C-16, 25-Sep-2024
Where it was sold
FL, MA, NJ, NY, PA, and VA
What to do if you have this product
- Compare the lot number and expiration date on your package with the codes above.
- Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
- If you have symptoms you think are related, contact your doctor. In an emergency call 911.
- Report side effects to FDA MedWatch at 1-800-FDA-1088.
Recall details
- Recall number
- D-0007-2025
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- Sep 23, 2024
- FDA report date
- Oct 9, 2024
- Quantity
- 99 doses
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Advanced Accelerator Applications USA, Inc.
Original FDA data
Every field from FDA enforcement report D-0007-2025, exactly as published.
Show all FDA fields
- City
- Millburn
- State
- NJ
- Status
- Ongoing
- Country
- United States
- Event ID
- 95420
- Address
- 57 E Willow St
- Code information
- Lot#: LPS240919B-16, 24-Sep-2024 Lot#: LPS240920B-16, 25-Sep-2024 Lot#: LPS240920C-16, 25-Sep-2024
- Postal code
- 07041-1416
- Report date
- Oct 9, 2024
- Product type
- Drugs
- Recall number
- D-0007-2025
- Classification
- Class II
- Recalling firm
- Advanced Accelerator Applications USA, Inc.
- Product quantity
- 99 doses
- Reason for recall
- CGMP deviations
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- 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
- Distribution pattern
- FL, MA, NJ, NY, PA, and VA
- Recall initiation date
- Sep 23, 2024
- Initial firm notification
- Letter
- Center classification date
- Oct 3, 2024