Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
Florbetaben F-18 (Neuraceq¿) Injection Solution 1.4 to 135 mCi/mL Recalled by Sofie Co dba Sofie Due to Lack of Assurance of Sterility: out-of-specification test results...
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact Sofie Co dba Sofie directly.
Affected 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
Quantity: 6 patient doses
Why Was This Recalled?
Lack of Assurance of Sterility: out-of-specification test results observed for Filter Integrity Test (FIT).
Where Was This Sold?
This product was distributed to 1 state: VA
About Sofie Co dba Sofie
Sofie Co dba Sofie has 1 total recall tracked by RecallDetector.
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Data sourced from the FDA (Drug). Last updated March 26, 2026. View original report