Renaissance Lakewood, LLC recalls Fluconazole Injection, USP, Iso-Osmotic Sodium Chloride Diluent, 400 mg in 200 mL (2 mg/mL), 200 mL Single Dose Flexibl…

Recall date

July 11, 2018

Source

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

Recall number

D-1031-2018

FDA classification

Class III

Brand / firm

Renaissance Lakewood, LLC

Sold / distributed

Nationwide and Puerto Rico

Why it was recalled

Superpotent Drug and Failed Stability Specifications: lot out of specification for elevated sodium chloride and elevated water vapor.

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

What was recalled

Fluconazole Injection, USP, Iso-Osmotic Sodium Chloride Diluent, 400 mg in 200 mL (2 mg/mL), 200 mL Single Dose Flexible Container bag, Rx only, Manufactured for: Claris Lifesciences Inc., North Brunswick, NJ 08902; By: Claris Injectables Ltd., Gujarat, India; NDC 36000-003-06.