Viatrexx Bio is voluntarily recalling 10 mL sterile injectable vials of products, listed in the table below with lot numbers, to the consumer level. The products were sold exclusively to practitioners for office use. The products were manufactured in a manner that cannot guarantee its sterility.
Administration of a non-sterile product, intended to be sterile, may result in a site-specific or systemic infection, which in turn may cause hospitalization, significant morbidity, or a fatal outcome. To date, Viatrexx has not received any reports of adverse events related to this recall.
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These products have a very limited distribution to less than 32 US practitioners. They are only for the 10mL sterile injectable products.
Viatrexx is notifying its customers by email and phone and is arranging for the return and replacement of all recalled products. Practitioners that have any of the 10 mL sterile injectable product which is being recalled should stop using/return to Viatrexx or discard.
Consumers with questions regarding this recall can contact Viatrexx by calling 450-536-1295 or info@viatrexx.com, from Monday to Friday, between 9 am to 3 pm EST (closed between 1 and 2 pm EST). Consumers should contact their physician if they have experienced any problems that may be related to taking or using this drug product.