Sofie Co dba Sofie Recall: Florbetaben F-18 (Neuraceq¿) Injection Solution 1.4 to 135 mCi/
Sofie Co dba Sofie Recall: Florbetaben F-18 (Neuraceq¿) Injection Solution 1.4 to 135 mCi/ is one of 9,000 recalls in the RecallGuard dataset. Key details — Recalling firm: Sofie Co dba Sofie; Product: Florbetaben F-18 (Neuraceq¿) Injection Solution 1.4 to 135 mCi/mL, 50 mL in 1 multi-dose glass vial, Diagnostic-For In
| Recalling firm | Sofie Co dba Sofie |
|---|---|
| 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). |
| Classification | Class II (moderate — may cause temporary or reversible health consequences) |
| Status | Terminated |
| Distribution | Product was released to one facility in VA. |
| Recall initiated | 20230822 |
| Recall number | D-1177-2023 |
| Category | drug |
| State | VA |
| Country | United States |
$29/mo
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