Risk Statement: In immunocompromised patients, the use of the affected product could potentially result in severe or life-threatening adverse events such as bacteremia/sepsis, pneumonia, invasive fungal rhinosinusitis, or disseminated fungal infection. In non-immunocompromised patients, the population most likely to use the product, the use of the defective product may result in infectious complications, for instance bacteremia or noninvasive fungal rhinosinusitis, but in this population the infections are expected to be less severe and more readily responsive to treatment.
To date, Buzzagogo has not received any complaints related to microbial concerns or reports of adverse events related to this recalled lot.
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