Product: Florbetaben F-18 (Neuraceq¿) Injection Solution 1.4 to 135 mCi/mL, 50 mL in 1 multi-dose glass vial, Diagnostic-For Intravenous Use Only, Manufactured by SOFIE Co dba SOFIE, Dulles, VA 20166 for Life Molecular Imagining Ltd., NDC 54828-001-50
Reason for recall: Lack of Assurance of Sterility: out-of-specification test results observed for Filter Integrity Test (FIT).
Recall initiated: 20230822
Status: Terminated
Classification: Class II
Recall type: Voluntary: Firm initiated