HIGH

Immunocore Recalls KIMMTRAK Injection Due to Subpotency

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.

Quick Facts at a Glance

Recall Date
June 10, 2025
Hazard Level
HIGH
Brand
IMMUNOCORE
Category
Health & Personal Care
Sold At
Multiple Retailers
Geographic Scope
1 states
At-Risk Groups
GENERAL

Hazard Information

Subpotent Drug

What You Should Do

Consumers and healthcare providers should stop using this product immediately. Contact IMMUNOCORE, LLC or your healthcare provider for guidance. Notification method: N/A

Product Details

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 Hazard

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.

Reported Incidents

No specific injuries or incidents have been reported related to this recall. However, the potential for inadequate treatment poses a significant risk to patients.

What to Do

Consumers and healthcare providers must stop using KIMMTRAK immediately. Contact Immunocore, LLC or consult with your healthcare provider for further guidance.

Contact Information

For more information, contact Immunocore at the customer service number provided on their official website.

Key Facts

  • Recall date: June 10, 2025
  • Total quantity recalled: 7,572 vials
  • Hazard: Subpotent drug
  • Class II recall
  • Manufactured in Denmark

Safety Assessment

Risk LevelHIGH
Severity Score
8/ 10
Affected Groups
GENERAL
Injury Types
OTHER

Product Classification

Product Details

Model Numbers
NDC 80446-0401-01 Lot #: 3D009AA09
3D009AA10
3D009AA25
NDC 80446-0401-99 Lot #: 3D009AA02
Affected States
ALL
Report Date
September 10, 2025
Source Agency
FDA - Drug Safety
Recall Status
ACTIVE

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