Curium US, LLC has recalled 5,160 vials (172 kits) of the Kit for the Preparation of Technetium Tc 99m Sestamibi Injection because of improper crimps on the vials. This defect compromises the seal of the vials, meaning the manufacturer cannot guarantee the product is sterile. Each affected kit contains 30 reaction vials used to prepare diagnostic imaging injections.
If the vial seal is not properly crimped, the medication may become contaminated with bacteria or other pathogens. Injecting a non-sterile product into a patient can lead to serious, life-threatening infections.
Quantity: 5,160 vials (172 kits of 30 vials each). Each vial contains Tetrakis (2-methoxy isobutyl isonitrile) Copper (I) tetratluoroborate - 1 mg; Stannous Chloride Dihydrate - 0.D75 mg; L-Cysteine Hydrochloride Monohydrate - 1 mg; Sodium Citrate Dihydrate - 2.6 mg; Mannitol - 20 mg.
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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