Low risk — use of or exposure to this product is not likely to cause adverse health consequences.
Fluconazole Injection Recalled by Renaissance Lakewood, LLC Due to Superpotent Drug and Failed Stability Specifications: lot out...
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, 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.
Quantity: 3000 bags
Why Was This Recalled?
Superpotent Drug and Failed Stability Specifications: lot out of specification for elevated sodium chloride and elevated water vapor.
Where Was This Sold?
This product was distributed nationwide across all 50 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