Viatrexx Bio Incorporated Issues Voluntary Nationwide Recall of Sterile Injectables Due to a Lack of Sterility Assurance

Summary

Company Announcement

Viatrexx Bio Incorporated, Newark, Delaware 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.

The products are used as sterile injectables and packaged in a 10 mL vial. The affected lots are included in the table.

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 [email protected], 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.

Adverse reactions or quality problems experienced with the use of this product may be reported to the FDA’s MedWatch Adverse Event Reporting program either online, by regular mail or by fax.

• Complete and submit the report Online
• Regular Mail or Fax: Download form or call 1- 800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178

This recall is being conducted with the knowledge of the U.S. Food and Drug Administration.