IMMUNOCORE, LLC: Drug Recall
Recall #D-0614-2025 · 06/10/2025
Class II: Risk
Recall Details
- Recall Number
- D-0614-2025
- Classification
- Class II
- Product Type
- Drug
- Recalling Firm
- IMMUNOCORE, LLC
- Status
- Ongoing
- Date Initiated
- 06/10/2025
- Location
- Conshohocken, PA, United States
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 7,572 vials
Reason for Recall
Subpotent Drug
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
Distribution Pattern
US Nationwide
Data from FDA openFDA enforcement reports. This site is not affiliated with or endorsed by the FDA. Recall information may be updated by the FDA at any time.