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.
Reason for recall: Superpotent Drug: High out of specification results for levofloxacin resulting in increased concentration of solution.
Recall initiated: 20180925
Status: Terminated
Classification: Class III
Recall type: Voluntary: Firm initiated