Baxter Healthcare Corporation recalls 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
Recalled October 3, 2018 · FDA recall D-1215-2018 · Baxter Healthcare
Hazard
Superpotent Drug: High out of specification results for levofloxacin resulting in increased concentration of solution. · FDA Class III
Units
523,896 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, 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.
Manufacturer(s)
Baxter Healthcare Corporation
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →