FUSION IV Pharmaceuticals, Inc dba. AXIA Pharmaceutical is voluntarily recalling all unused sterile drug products within expiry” FDA (2019).
FDA report “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.”
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