FDA announces drug product recall due to lack of sterility assurance
FUSION IV Pharmaceuticals, Inc dba AXIA Pharmaceutical is voluntarily recalling all unused sterile drug products to the user level as they do not adhere to federal guidelines.
FUSION IV Pharmaceuticals, Inc dba AXIA Pharmaceutical has informed the US Food and Drug Administration (FDA) that it is voluntarily recalling all unused sterile drug products within expiry, to the user level.
This is due to a lack of assurance of sterility as the recalled sterile products have been found to be inconsistent with federal guidelines.
Administration of a drug product intended to be sterile and is not could result in serious infections which may be life-threatening, the company said. 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 products out of an abundance of caution and to promote patient safety, which it said is its highest priority.
FUSION IV Pharmaceuticals, Inc dba. AXIA Pharmaceutical has said it is notifying its customers by letter and direct outreach and is arranging for the return of all recalled products. The company also said that customers that have any recalled products should stop using them and return them to the company.
A full list of the products, including lot numbers and expiration dates, being recalled, can be found here.