Class II — Potential Health Hazard

Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.

Fluconazole Injection Recalled by Baxter Healthcare Corporation Due to Lack of Assurance of Sterility: confirmed customer complaints...

Date: December 6, 2016
Company: Baxter Healthcare Corporation
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 Baxter Healthcare Corporation directly.

Affected Products

Fluconazole Injection, USP, 200 mg/100 mL (2mg/mL), 100 mL Single-Dose Intravia Container bag, Rx only, Baxter Healthcare Corporation, Deerfield, IL 60015 USA, Product Code 2J1446, NDC 0338-6046-48.

Quantity: 30,910 bags

Why Was This Recalled?

Lack of Assurance of Sterility: confirmed customer complaints of leaking bags.

Where Was This Sold?

United States, United Arab Emirates, and Colombia

About Baxter Healthcare Corporation

Baxter Healthcare Corporation has 401 total recalls tracked by RecallDetector.

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