Sofie Co dba Sofie has recalled 6 patient doses of Florbetaben F-18 (Neuraceq) Injection Solution due to a lack of sterility assurance. The recall was initiated after a filter integrity test produced results that did not meet required specifications. This diagnostic drug is administered intravenously in 50 mL multi-dose glass vials and was distributed to a single facility in Virginia.
A lack of sterility assurance in an injectable medication means the product may contain harmful bacteria or other microorganisms. Injecting a contaminated product directly into the bloodstream poses a risk of serious infection or sepsis to the patient.
EOS: 22 Aug 2023/08:25; Recall #: D-1177-2023
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.
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Sources: FDA iRES · Raw API Response
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