Immunocore recalled 7,572 vials of KIMMTRAK (tebentafusp-tebn) Injection due to subpotency concerns. This defect may compromise treatment efficacy for patients. Healthcare providers and patients should stop using the product immediately and consult for guidance.
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
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KIMMTRAK (tebentafusp-tebn) Injection is used for treating specific cancers. Patients buy this product as part of their treatment regimen for serious health conditions, particularly melanoma.
The drug's subpotency means it may not contain the necessary potency to effectively treat patients, potentially compromising their health and treatment outcomes.
This recall is not part of a broader industry pattern.
Patients relying on KIMMTRAK for cancer treatment may face disruption in their regimen, leading to possible treatment delays or ineffectiveness.
Lot numbers and expiration dates are typically printed on the product packaging or the vial label itself.
Expect resolution for refunds or replacements within 4-6 weeks after contacting the manufacturer or your healthcare provider.
Keep records of your KIMMTRAK injections, including lot numbers, expiration dates, and any correspondence regarding the recall.
- Product: KIMMTRAK (tebentafusp-tebn) Injection 100 mcg/0.5 mL - Manufactured by: Immunocore Limited - Product of: Denmark - Lot Numbers: 3D009AA09, 3D009AA10, 3D009AA25, 3D009AA02 - Expiration Date: March 31, 2026 - NDC Numbers: 80446-0401-01, 80446-0401-99 - Quantity: 7,572 vials
No injuries or incidents have been reported.
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