Class II
Terminated
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
- Company
- Sofie Co Dba Sofie
- Recall Initiated
- August 22, 2023
- Posted
- October 4, 2023
- Recall Number
- D-1177-2023
- Voluntary / Mandated
- Voluntary: Firm initiated
- Quantity
- 6 patient doses
- Firm Location
- Sterling, VA, United States
Reason for Recall
Lack of Assurance of Sterility: out-of-specification test results observed for Filter Integrity Test (FIT).
Distribution
Product was released to one facility in VA.
Lot / Code Info
Batch # FBBVA123082201, EOS: 22 Aug 2023/08:25, EXP: 22 Aug 2023/18:25
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