Sofie Co dba Sofie recalls Florbetaben F-18 (Neuraceq¿) Injection Solution 1.4 to 135 mCi/mL, 50 mL in 1 multi-dose glass vial, Diagnostic-For Intr
Recalled October 4, 2023 · FDA recall D-1177-2023 · Sofie Co
Hazard
Lack of Assurance of Sterility: out-of-specification test results observed for Filter Integrity Test (FIT). · FDA Class II
Units
6 patient doses
Sold at
Product was released to one facility in VA.
Description
Lack of Assurance of Sterility: out-of-specification test results observed for Filter Integrity Test (FIT).
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
Manufacturer(s)
Sofie Co dba Sofie
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →