Class II — Potential Health Hazard

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

0.9% Sodium Chloride Injection Recalled by Fresenius Medical Care Renal Therapies Group, LLC Due to Lack of Assurance of Sterility

Date: November 13, 2017
Company: Fresenius Medical Care Renal Therapies Group, 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 Fresenius Medical Care Renal Therapies Group, LLC directly.

Affected Products

0.9% Sodium Chloride Injection, USP, 1000 mL, Rx Only, Fresenius Medical Care North America, Waltham, MA 02451, NDC 49230-0300-10.

Quantity: 25,356 1 liter bags

Why Was This Recalled?

Lack of Assurance of Sterility

Where Was This Sold?

Product was distributed throughout the United States.

About Fresenius Medical Care Renal Therapies Group, LLC

Fresenius Medical Care Renal Therapies Group, LLC has 27 total recalls tracked by RecallDetector.

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