FDASeptember 25, 2018drug

Levofloxacin Injection in 5% Dextrose, 5 mg/mL, packaged in a) 50 mL (NDC 36000-046-24), b) 100 mL (NDC 36000-047-24), c) 150 mL (NDC 36000-048-24) Container bags, Rx only, Manufactured for: Claris Lifesciences Inc., North Brunswick, NJ 08902; By: Claris Injectables Ltd., Gujarat, India.

Official recall recorded by the U.S. Food & Drug Administration.

The hazard

Superpotent Drug: High out of specification results for levofloxacin resulting in increased concentration of solution.

What to do

FDA enforcement status: Terminated

Brands named

baxter healthcarebaxter

Recall history

Other federal recalls tied to the same brand — a factual pattern, straight from the source data.

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