NEURACEQ Florbetaben F-18 (Neuraceq) Injection Solution 1.4 to 135 mCi/mL, 50 mL in 1 recall — FDA D-1177-2023
Lack of Assurance of Sterility: out-of-specification test results observed for Filter Integrity Test (FIT).
Overview of recall records associated with Sofie Co dba Sofie, including dates, categories and classifications where available.
Classification mix: Class II: 1.
Lack of Assurance of Sterility: out-of-specification test results observed for Filter Integrity Test (FIT).
This page summarizes recall records in which the official source identifies Sofie Co dba Sofie as the recalling firm or manufacturer. The number of records should not be treated as a safety rating or a measure of company size, because recall counts depend on product mix, reporting periods and how government records are organized.
Compare the dates, categories and classifications together rather than relying on the total alone. Open an individual record for the recalled product, reason, distribution details and current instructions available from the source.