Safety Alert: Class II: Subpotent Drug
healthClass IIRecalled on Sep 10, 2025
KIMMTRAK (tebentafusp-tebn) Injection, 100 mcg/0.5 mL, For intravenous Infusion After Dilution, Single-Does vial
🔢 7,572 vials
Sold At: IMMUNOCORE, LLC(US Nationwide)
Recall #: FDA-DRUG-D-0614-2025
Source: FDA-ENFORCEMENT
Product Identification
- Lot/Batch Codes:
- 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
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Summary
Subpotent Drug
What to do next
- 1Stop using this product - may cause temporary or medically reversible health problems
- 2Check with retailer or manufacturer for recall status and remedy options
- 3Contact IMMUNOCORE, LLC for return or refund information
- 4Visit the official FDA recall page for complete details
Summaries only; always follow the official notice.