IMMUNOCORE, LLC recalls KIMMTRAK (tebentafusp-tebn) Injection, 100 mcg/0.5 mL, For intravenous Infusion After Dilution, Single-Does vial. Mfd b…

Recall date

June 10, 2025

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

D-0614-2025

FDA classification

Class II

Brand / firm

IMMUNOCORE, LLC

Sold / distributed

US Nationwide

Why it was recalled

Subpotent Drug

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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