Class III โ€” Low Risk

Low risk โ€” 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: lots out of specification for elevated...

Date: July 11, 2018
Company: Renaissance Lakewood, LLC
Status: Terminated
Source: FDA (Drug)

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), 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.

Quantity: 12088 bags

Why Was This Recalled?

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

Where Was This Sold?

This product was distributed nationwide across all 50 states.

Affected (51 states)Not affected

About Renaissance Lakewood, LLC

Renaissance Lakewood, LLC has 6 total recalls tracked by RecallDetector.

Related Recalls

Data sourced from the FDA (Drug). Last updated March 26, 2026. View original report