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

Recall Number: D-0605-2018

Firm: Renaissance Lakewood, LLC

Classification: Class III

Status: Terminated

Report Date: 20180404

Initiation Date: 20180302

Termination Date: 20200410

Superpotent and Failed Stability Specifications; out of specification results for assay and water vapor permeability

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