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Baxter Healthcare Corporation recalls Levofloxacin Injection in 5% Dextrose, 500 mg (5 mg/mL), 500 mg in 100 mL 5% Dextrose, 100 mL Single Use Container bag,

Recalled August 15, 2018 · FDA recall D-1035-2018 · Baxter Healthcare

Hazard
Superpotent Drug: High out of specification results for levofloxacin resulting in increased concentration of solution. · FDA Class III
Units
106,320 bags
Sold at
Nationwide USA and Puerto Rico

Description

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

Product
Levofloxacin Injection in 5% Dextrose, 500 mg (5 mg/mL), 500 mg in 100 mL 5% Dextrose, 100 mL Single Use Container bag, Rx only, Manufactured for: Claris Lifesciences Inc., North Brunswick, NJ 08902; By: Claris Injectables Ltd., Gujarat, India, NDC 36000-047-24.
Manufacturer(s)
Baxter Healthcare Corporation

Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →

Baxter Healthcare Corporation recalls Levofloxacin Injection in 5% Dextrose, 500 mg (5 mg/mL), 500 mg in 100 mL 5% Dextrose, 100 mL Single Use Container bag, | RecallWatchUSA