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Levofloxacin

FDA recalls

5 rows

Date	Company and reason	Class
Apr 12, 2022	McKesson Medical-Surgical Inc. Corporate Office cGMP deviations: Temperature abuse	Class II · Terminated
Mar 14, 2021	Cardinal Health Inc. CGMP Deviations: Intermittent exposure to temperature excursion during storage.	Class II · Terminated
Sep 24, 2018	Baxter Healthcare Corporation Superpotent Drug: High out of specification results for levofloxacin resulting in increased concentration of solution.	Class III · Terminated
Jul 31, 2018	Baxter Healthcare Corporation Superpotent Drug: High out of specification results for levofloxacin resulting in increased concentration of solution.	Class III · Terminated
Mar 9, 2017	Claris Lifesciences Inc Lack of Assurance of Sterility: there is potential of a leak from the primary container which may result in a potential breach of sterility and contamination of the product.	Class II · Terminated

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Sources: CMS Medicare Part D Prescribers 2024; CMS Open Payments 2025 (general payments; a payment is not evidence of wrongdoing); FDA enforcement reports (openFDA).