Leventon S. A. U DOSI-FUSER 12591 5-500D1 -USA, 12591 5-600D1 -USA Provide parenteral drug recall — FDA Z-2360-2019
The product lacks 510(k) clearance, and therefore is misbranded and must be removed from the U.S. market.
Overview of recall records associated with Leventon S. A. U., including dates, categories and classifications where available.
Classification mix: Class II: 1.
The product lacks 510(k) clearance, and therefore is misbranded and must be removed from the U.S. market.
This page summarizes recall records in which the official source identifies Leventon S. A. U. 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.