Lev5 recalled over labeling errors

Recall date

December 23, 2024

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Official notice title

Oxoid Limited recalls Lev5, REF CT1587B, 50 Susceptibility discs Levofloxacin 5 ug, IVD, CE 2797

Recall number

Z-1075-2025

FDA classification

Class II

Brand / firm

Oxoid Limited

Sold / distributed

US: VA, CA, NE, MA, FL, CA, MA, NH, WA OUS: Austria, Australia, Brazil, Canada, China, Costa Rica, Germany, Spain, France, United Kingdom, Ghana, Hong Kong, South Korea, Netherlands, Peru, Philippines, Poland, Indonesia

Why it was recalled

Mislabeling; Levofloxacin Antimicrobial susceptibility disc packaging may contain Norfloxacin Antimicrobial Susceptibility discs.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

Lev5, REF CT1587B, 50 Susceptibility discs Levofloxacin 5 ug, IVD, CE 2797