Baxter Healthcare Corporation recalls Levofloxacin Injection in 5% Dextrose, 750 mg (5 mg/mL), 750 mg in 150 mL 5% Dextrose, 150 mL Single Use Container bag,
Recalled August 15, 2018 · FDA recall D-1036-2018 · Baxter Healthcare
Hazard
Superpotent Drug: High out of specification results for levofloxacin resulting in increased concentration of solution. · FDA Class III
Units
711,216 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, 750 mg (5 mg/mL), 750 mg in 150 mL 5% Dextrose, 150 mL Single Use Container bag, Rx only, Manufactured for: Claris Lifesciences Inc., North Brunswick, NJ 08902; By: Claris Injectables Ltd., Gujarat, India, NDC 36000-048-24.
Manufacturer(s)
Baxter Healthcare Corporation
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →