FDA-Drug2023-10-04Class II
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
Sofie Co dba Sofie
Hazard
Lack of Assurance of Sterility: out-of-specification test results observed for Filter Integrity Test (FIT).
Sold states
Product was released to one facility in VA.
Affected count
6 patient doses
Manufactured in
100 Executive Dr Ste 6, N/A, Sterling, VA, United States
Products
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
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1177-2023Don't want to check this manually?
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