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: customer complaints received...

Date: May 15, 2017
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: 113,590 bags

Why Was This Recalled?

Lack of assurance of sterility: customer complaints received for the presence of leaks.

Where Was This Sold?

US and foreign countries: United Arab Emirates, Colombia, and Canada

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