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

Date: November 11, 2017
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, 2 mg/mL, a) 50 mL (NDC 336000-261-10) and b) 100 mL (NDC 33600-002-10), Rx Only, Manufactured for: Claris LifeSciences, Inc. North Brunswick, NJ 08902 By: Claris Injectables Ltd., Gujarat, India

Quantity: 24,569 bags

Why Was This Recalled?

Superpotent

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