Product: Fluconazole Injection, USP, Iso-Osmotic Sodium Chloride Diluent, 200 mg in 100 mL (2 mg/mL), 100 mL Single Dose Flexible Container bag, Rx only, Manufactured for: Claris Lifesciences Inc., North Brunswick, NJ 08902; By: Claris Injectables Ltd., Gujarat, India, NDC a) 36000-002-10 and b) 36000-002-06.
Reason for recall: Superpotent Drug: lots out of specification for elevated sodium chloride and fluconazole assay.
Recall initiated: 20180711
Status: Terminated
Classification: Class III
Recall type: Voluntary: Firm initiated