Company Announcement Date: January 15, 2020

FDA Publish Date: January 16, 2020

Product Type: Drugs

Reason for Announcement: Lack of Assurance of Sterility

Company Name: FUSION IV Pharmaceuticals, Inc dba. AXIA Pharmaceutcal

Brand Name: AXIA Pharmaceutical

Product Description: Sterile Drug Products

FUSION IV Pharmaceuticals, Inc 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 Pharmaceuticals, Inc dba. AXIA Pharmaceutical 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, which is AXIA pharmaceutical’s highest priority.

For a full listing of the products, including lot numbers and expiration dates, being recalled, please follow this link: http://www.axiapharma.net/recalls.html

External Link Disclaimer

. Sterile drug product was distributed nationwide to consumers.

FUSION IV Pharmaceuticals, Inc dba. AXIA Pharmaceutical is notifying its customers by letter and direct outreach. FUSION IV Pharmaceuticals, Inc dba. AXIA Pharmaceutical is arranging for the return of all recalled products. Customers that have any recalled products should stop using and return to FUSION IV Pharmaceuticals, Inc dba. AXIA Pharmaceutical.

Consumers with questions regarding this recall can contact FUSION IV Pharmaceuticals, Inc dba. AXIA Pharmaceutical Erdwin Orellana by phone number: (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.

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.

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