Pluvicto, 1000 MBq/mL (27 mCi/mL), lutetium, LU 177, vipivotide tetraxetan injection, Sing… recall
FDA recall D-0007-2025 · initiated Sep 23, 2024
Advanced Accelerator Applications USA, Inc. recalled Pluvicto, 1000 MBq/mL (27 mCi/mL), lutetium, LU 177, vipivotide tetraxetan injec… in Sep 2024 — an FDA Class II recall (D-0007-2025) because CGMP deviations.
May cause temporary or medically reversible harm; low probability of serious harm.
Why it was recalled
CGMP deviations
The manufacturing process itself
The FDA found the process itself out of compliance, usually before any defective product was identified.
This is a manufacturing or quality failure, not a finding that the medicine is unsafe to take — across every recall we hold, none was issued for that reason. It does not mean the batch was harmless.
Is your product affected? Check the lot number
A recall covers only specific lots. Find the lot number and expiration date on your package and compare them to the affected codes below — if yours is not listed, it was not part of this recall.
Quantity recalled: 99 doses
Details
- 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
- Recalling company
- Advanced Accelerator Applications USA, Inc.
- Classification
- Class II
- Status
- Ongoing
- Type
- Voluntary: Firm initiated
- Distribution
- FL, MA, NJ, NY, PA, and VA
- Initiated
- Sep 23, 2024
- FDA report date
- Oct 9, 2024
Frequently asked
- Was Pluvicto, 1000 MBq/mL (27 mCi/mL), lutetium, LU 177, vipivotide tetraxetan injec… recalled?
- Advanced Accelerator Applications USA, Inc. recalled Pluvicto, 1000 MBq/mL (27 mCi/mL), lutetium, LU 177, vipivotide tetraxetan injec… in Sep 2024 — an FDA Class II recall (D-0007-2025) because CGMP deviations. May cause temporary or medically reversible harm; low probability of serious harm.
- Why was Pluvicto, 1000 MBq/mL (27 mCi/mL), lutetium, LU 177, vipivotide tetraxetan injec… recalled?
- Per the FDA enforcement record, the reason for recall D-0007-2025 was: CGMP deviations
- Is a recalled Pluvicto, 1000 MBq/mL (27 mCi/mL), lutetium, LU 177, vipivotide tetraxetan injec… dangerous to take?
- An FDA recall removes specific lots from the market for a defined reason and does not by itself mean the medicine is unsafe for everyone — your specific lot may never have been affected. May cause temporary or medically reversible harm; low probability of serious harm. Check the FDA notice for the affected lot numbers and expiration dates, and ask your pharmacist or doctor before stopping a prescribed medicine. This reproduces public FDA data and is not medical advice.
- Which lots of Pluvicto, 1000 MBq/mL (27 mCi/mL), lutetium, LU 177, vipivotide tetraxetan injec… are affected?
- Distributed: FL, MA, NJ, NY, PA, and VA. The recall covers these lots — Lot#: LPS240919B-16, 24-Sep-2024 Lot#: LPS240920B-16, 25-Sep-2024 Lot#: LPS240920C-16, 25-Sep-2024. Check the lot number and expiration date on your package against this list; if yours is not listed, it was not part of recall D-0007-2025.