Immunocore, LLC is recalling 7,572 vials of KIMMTRAK (tebentafusp-tebn) Injection, 100 mcg/0.5 mL. The medication, which is used for intravenous infusion after dilution, was found to be subpotent, meaning it may not contain the full strength required to be effective. The recall affects four specific lots of single-dose vials manufactured in Denmark.
A subpotent drug may not provide the intended therapeutic effect, which can lead to inadequate treatment or disease progression for the patient. No specific injuries or clinical failures have been reported in the recall notice.
NDC 80446-0401-99 is labeled as Non-Commercial FG.
If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.
This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.
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Sources: FDA iRES · Raw API Response
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