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…

Recall date

March 2, 2018

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

D-0605-2018

FDA classification

Class III

Brand / firm

Renaissance Lakewood, LLC

Sold / distributed

Nationwide

Why it was recalled

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

Class III means the product violates regulations but is not likely to cause harm.

What was recalled

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