Levofloxacin Injection in 5% Dextrose, 750 mg in 150 mL 5% Dextrose, Rx only, Manufactured for: Claris Lifesciences Inc. North Brunswick NJ, 08902, By: Claris Injectable Ltd. Gujarat, India, NDC 36000-048-24

Recall Number: D-0615-2017

Firm: Claris Lifesciences Inc

Classification: Class II

Status: Terminated

Report Date: 20170405

Initiation Date: 20170310

Termination Date: 20200918

Lack of Assurance of Sterility: there is potential of a leak from the primary container which may result in a potential breach of sterility and contamination of the product.

Levofloxacin Injection in 5% Dextrose, 750 mg in 150 mL 5% Dextrose, Rx only, Manufactured for: Claris Lifesciences Inc. North Brunswick NJ, 08902, By: Claris Injectable Ltd. Gujarat, India, NDC 36000-048-24