FUSION IV Pharmaceuticals dba AXIA Pharmaceutical is voluntarily recalling all unused sterile drug products within expiry, to the user level, due to a lack of assurance of sterility. The recalled sterile products have been found to be inconsistent with federal guidelines.
Administration of a drug product intended to be sterile that is not sterile could result in serious infections which may be life-threatening. To date, FUSION IV has not received any reports of adverse events related to this recall and is recalling all sterile products out of an abundance of caution and to promote patient safety.
For a full listing of the products, including lot numbers and expiration dates, being recalled, go to the company’s website. Sterile drug product was distributed nationwide to consumers.
FUSION IV is notifying its customers by letter and direct outreach. FUSION IV is arranging for the return of all recalled products. Customers that have any recalled products should stop using and return to FUSION IV.
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Consumers with questions regarding this recall can contact FUSION IV, Erdwin Orellana, by phone number: (877-685-8222Call: 877-685-8222) or e-mail address ecallassistance@axiapharma.net, Monday through Friday: 8:00 AM to 4:00 PM PST. Consumers should contact their physician or healthcare provider if they have experienced any problems that may be related to taking or using this drug product.
This recall is being conducted with the knowledge of the U.S. Food and Drug Administration.