Class II โ€” Potential Health Hazard

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

0.9% Sodium Chloride Injection Recalled by Baxter Healthcare Corp. Due to Lack of Assurance of Sterility. Complaints were receive...

Date: March 18, 2015
Company: Baxter Healthcare Corp.
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 Corp. directly.

Affected Products

0.9% Sodium Chloride Injection, USP, 500 mL in VIAFLEX Plastic Container, Rx only, Manufactured by Baxter Healthcare Corp., North Cove, North Carolina Facility Highway 221 North, Marion, NC 28752 for Baxter Healthcare Corporation, One Baxter Parkway, Deerfield, IL 60015. NDC 0338-0049-03

Quantity: 597,498 units total

Why Was This Recalled?

Lack of Assurance of Sterility. Complaints were receive of missing closures and/or leaks which may compromise product sterility.

Where Was This Sold?

This product was distributed nationwide across all 50 states.

Affected (51 states)Not affected

About Baxter Healthcare Corp.

Baxter Healthcare Corp. has 126 total recalls tracked by RecallDetector.

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