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),…

Recall date

September 25, 2018

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

D-1215-2018

FDA classification

Class III

Brand / firm

Baxter Healthcare Corporation

Sold / distributed

Nationwide USA and Puerto Rico

Why it was recalled

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

Class III means the product violates regulations but is not likely to cause harm.

What was recalled

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.