Reported Oct 4, 2023 · Terminated
Florbetaben F-18 (Neuraceq¿) Injection Solution 1.4 to 135 mCi/mL, 50 mL in 1 multi-dose glass vial, Diagnostic-For…
Sofie Co. dba Sofie
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Sofie Co dba Sofie · 100 Executive Dr Ste 6 · Sterling, VA · 20166-9507
Is this the product you have?
- 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
- Lot codes and dates
- Batch # FBBVA123082201
- EOS22
- Aug 2023/0825
- EXP22
- Aug 2023/1825
- Amount recalled
- 6 patient doses
Where it was sold
Why it was recalled
Lack of Assurance of Sterility: out-of-specification test results observed for Filter Integrity Test (FIT).
This product could cause temporary or reversible health problems — stop using it.
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