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.
Reason for recall: Superpotent Drug: High out of specification results for levofloxacin resulting in increased concentration of solution.
Recall initiated: 20180801
Status: Terminated
Classification: Class III
Recall type: Voluntary: Firm initiated