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-1033-2018

FDA classification

Class III

Brand / firm

Renaissance Lakewood, LLC

Sold / distributed

Nationwide and Puerto Rico

Why it was recalled

Superpotent Drug: lots out of specification for elevated sodium chloride and fluconazole assay.

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 a) 36000-002-10 and b) 36000-002-06.