Product: Fluconazole Injection, USP, 400 mg in 200 mL, Rx only, Manufactured for: Claris Lifesciences Inc. North Brunswick NJ, 08902, By: Claris Injectable Ltd. Gujarat, India,  NDC 36000-003-06
Reason for recall: 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.
Recall initiated: 20170310
Status: Terminated
Classification: Class II
Recall type: Voluntary: Firm initiated