Renaissance Lakewood, LLC recalls Flucanazole Injection, USP 200 mg in in 100 mL (2 mg/mL), 10 Single Dose Flexible Containers, Rx Only, Manufactured for:
Recalled April 4, 2018 · FDA recall D-0605-2018 · Renaissance Lakewood
Hazard
Superpotent and Failed Stability Specifications; out of specification results for assay and water vapor permeability · FDA Class III
Units
1277 bags
Sold at
Nationwide
Description
Superpotent and Failed Stability Specifications; out of specification results for assay and water vapor permeability
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
Manufacturer(s)
Renaissance Lakewood, LLC
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →