Product: Flucanazole Injection, USP 200 mg in in 100 mL (2 mg/mL), 10 Single Dose Flexible Containers, Rx Only, Manufactured for: Claris Lifesciences, Inc. North Brunswick, NJ 08902 By; Claris Injectables Ltd. Gujarat, India --- NDC 36000-006-10
Reason for recall: Superpotent and Failed Stability Specifications; out of specification results for assay and water vapor permeability
Recall initiated: 20180302
Status: Terminated
Classification: Class III
Recall type: Voluntary: Firm initiated