FDAFDA · Food and drugs·Recall number 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 Life Molecular Imagining Ltd., NDC 54828-001-50
Published October 4, 2023 · Recall initiated: August 22, 2023
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Lack of Assurance of Sterility: out-of-specification test results observed for Filter Integrity Test (FIT).
What to do
Voluntary: Firm initiated · Telephone
Recall details
- Brand
- NEURACEQ
- Manufacturer
- Sofie Co dba Sofie
- Distributor
- Product was released to one facility in VA.
- Lot
- Batch # FBBVA123082201, EOS: 22 Aug 2023/08:25, EXP: 22 Aug 2023/18:25
- Risk classification
- Class II
- Area (FDA)
- drug
- Country
- United States
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