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,…

Recall date

August 1, 2018

Source

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

Recall number

D-1035-2018

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, 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.