Renaissance Lakewood, LLC recalls Fluconazole Injection, USP, Iso-Osmotic Sodium Chloride Diluent, 200 mg in 100 mL (2 mg/mL), 100 mL Single Dose Flexibl…

Recall date

July 11, 2018

Source

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

Recall number

D-1032-2018

FDA classification

Class III

Brand / firm

Renaissance Lakewood, LLC

Sold / distributed

Nationwide and Puerto Rico

Why it was recalled

Failed Stability Specifications: lot out of specification for 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, 200 mg in 100 mL (2 mg/mL), 100 mL Single Dose Flexible Container bag, Rx only, Manufactured for: Claris Lifesciences Inc., North Brunswick, NJ 08902; By: Claris Injectables Ltd., Gujarat, India, NDC 36000-002-10.