Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
Fluconazole Injection Recalled by Renaissance Lakewood, LLC Due to Labeling: Label mix-up - A complaint was received...
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact Renaissance Lakewood, LLC directly.
Affected Products
Fluconazole Injection, USP, Iso-Osmotic Sodium Chloride Diluent, 200 mg in 100 mL (2 mg/mL), package in 100 mL bags, Rx only, Manufactured for: Claris Lifesciences Inc., North Brunswick, NJ 08902, By: Claris Injectables Limited, Sarkhei-Bavla Road, Chacharwadi-Vasna, Ahmedabad, India 382213, NDC 36000-002-10
Quantity: 1784 bags
Why Was This Recalled?
Labeling: Label mix-up - A complaint was received of one bag of Fluconazole Injection, Iso-Osmotic Sodium Chloride Diluent, USP, 2mg/mL, 50 mL found within the package of 100 mL bags.
Where Was This Sold?
Product was distributed throughout the United States.
About Renaissance Lakewood, LLC
Renaissance Lakewood, LLC has 6 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Drug). Last updated March 26, 2026. View original report