Immunocore Limited recalled 7,572 vials of KIMMTRAK injection on June 10, 2025. The affected lots may not provide the intended therapeutic effect. Consumers and healthcare providers should stop using the product immediately.
Subpotent Drug
Consumers and healthcare providers should stop using this product immediately. Contact IMMUNOCORE, LLC or your healthcare provider for guidance. Notification method: N/A
The KIMMTRAK injection is a 100 mcg/0.5 mL solution for intravenous infusion after dilution. It was sold under NDC 80446-0401-01, with specific lot numbers 3D009AA09, 3D009AA10, 3D009AA25, and 3D009AA02. The product is manufactured in Denmark and was distributed nationwide.
The recall was initiated due to the drug being subpotent, meaning it may not deliver the intended dosage or therapeutic effect. This classification falls under Class II, indicating a high hazard level.
No specific injuries or incidents have been reported related to this recall. However, the potential for inadequate treatment poses a significant risk to patients.
Consumers and healthcare providers must stop using KIMMTRAK immediately. Contact Immunocore, LLC or consult with your healthcare provider for further guidance.
For more information, contact Immunocore at the customer service number provided on their official website.
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