KIMMTRAK (tebentafusp-tebn) Injection, 100 mcg/0.5 mL, For intravenous Infusion After Dilution, Single-Does vial. Mfd by: Immunocore Limited, 92 Park Drive, Abingdon, Oxfordshire, OX14 4RY, United Kingdom, For: Immunocore Commercial LLC, 181 Washington St, Conshohocken, PA, 19428, Product of Denmark NDC 80446-0401-01 Lot #: 3D009AA09, 3D009AA10, 3D009AA25, Exp Date: 31 MAR 2026 NDC 80446-0401-99 (Non-Commercial FG) Lot #: 3D009AA02, Exp Date 31 MAR 2026

This recall is currently active, issued September 10, 2025. It was issued by Immunocore, Llc.

Company

Immunocore, Llc

Recall Initiated

June 10, 2025

Posted

September 10, 2025

Recall Number

D-0614-2025

Voluntary / Mandated

Voluntary: Firm initiated

Quantity

7,572 vials

Firm Location

Conshohocken, PA, United States

Official Source

View on FDA website ↗