Drug Enforcement D-0614-2025

Subpotent Drug

Status

Ongoing

Classification

Class II

Report Date

September 10, 2025

Termination Date

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Product Information

Product description
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
Product quantity
7,572 vials
Reason for recall
Subpotent Drug
Recall initiation reason
—
Initial firm notification
N/A
Distribution pattern
US Nationwide

Location & Firm

Recalling firm
IMMUNOCORE, LLC
Address
Six Tower Bridge, 181 Washington St Ste 540

United States
Voluntary / Mandated
Voluntary: Firm initiated
Status date
—

Codes & Dates

Recall number
D-0614-2025
Event ID
97329
Recall initiation date
June 10, 2025
Center classification date
September 3, 2025
Code info
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
More code info
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