News & Press: Patient Safety

FUSION IV Pharmaceuticals Recalls All Sterile Drug Products Due to Lack of Assurance of Sterility

Tuesday, January 21, 2020  

SIS Patient Safety Alert 01/21/2020: FUSION IV Pharmaceuticals, Inc dba. AXIA Pharmaceutical Issues Voluntary Recall of All Sterile Drug Products Within Expiry Due to Lack of Assurance of Sterility

This is an important alert from the Spine Intervention Society. SIS sends Patient Safety Alerts when it receives important information regarding products or services that can impact your patients' safety. When the Food and Drug Administration (FDA) issues a safety alert, or a company announces a recall or market withdrawal, the FDA posts the announcement as a public service. In such cases neither SIS nor the FDA endorse either the product or the company.

ISSUE: FUSION IV Pharmaceuticals, Inc dba. AXIA Pharmaceutical is voluntarily recalling all unused sterile drug products within expiry 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.

Click here for a full listing of the products, including lot numbers and expiration dates, being recalled.

RECOMMENDATION: 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.

Health professionals and patients are encouraged to report adverse events or side effects related to the use of these products to the FDA's MedWatch Safety Information and Adverse Event Reporting Program:

Source: Food and Drug Administration - Accessed 01/21/2020


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