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Sofie Co dba Sofie recalls
FDA enforcement reports naming Sofie Co dba Sofie as the recalling firm.
Recall reports
1
Class I (serious)
0
Most recent report
Oct 4, 2023
All
1
Food
0
Drugs
1
Severity
All classes
Class I: serious
Class II: moderate
Class III: low
Date
Product
Reason
Class
Oct 4, 2023
Florbetaben F-18 (Neuraceq¿) Injection Solution 1
Drug · Sofie Co dba Sofie
Lack of Assurance of Sterility: out-of-specification test results observed for Filter Integrity Test (FIT).
Class II
