Reported Sep 10, 2025 · Ongoing
KIMMTRAK (tebentafusp-tebn) Injection, 100 mcg/0.5 mL, For intravenous Infusion After Dilution, Single-Does vial. Mfd…
Immunocore, LLC
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: IMMUNOCORE, LLC · Six Tower Bridge · Conshohocken, PA · 19428-2068
Is this the product you have?
- KIMMTRAK (tebentafusp-tebn) Injection, 100 mcg/0.5 mL, For intravenous Infusion After Dilution, Single-Does vial
- Mfd byImmunocore Limited, 92 Park Drive, Abingdon, Oxfordshire, OX14 4RY, United Kingdom
- ForImmunocore Commercial LLC, 181 Washington St, Conshohocken, PA, 19428, Product of Denmark NDC 80446-0401-01 Lot #: 3D009AA09, 3D009AA10, 3D009AA25
- Exp Date31 MAR 2026 NDC 80446-0401-99 (Non-Commercial FG) Lot #: 3D009AA02, Exp Date 31 MAR 2026
- Lot codes and dates
NDC 80446-0401-01 Lot #: 3D009AA093D009AA103D009AA25
- Exp Date31 MAR 2026 NDC 80446-0401-99 (Non-Commercial FG) Lot #: 3D009AA02, Exp Date 31 MAR 2026
- Amount recalled
- 7,572 vials
Where it was sold
- Nationwide
Why it was recalled
Subpotent Drug
This product could cause temporary or reversible health problems — stop using it.
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