FDARecalled Oct 4, 2023 · #D-1177-2023
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 Li...
Hazard
Class II — temporary health risk
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Lack of Assurance of Sterility: out-of-specification test results observed for Filter Integrity Test (FIT). Classification: Class II Distribution: Product was released to one facility in VA.
Product details
- 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
- Type
- Drugs
- Manufacturer
- Sofie Co dba Sofie
- Model numbers
- —
- UPCs
- —