Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
Sodium Chloride 0.9% Injection Recalled by Fresenius Medical Care Holdings, Inc. Due to Lack of assurance of sterility: The product was...
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 Holdings, Inc. directly.
Affected Products
Sodium Chloride 0.9% Injection, USP, 1000 mL bags, 12 bags per carton, Rx only, Fresenius Medical Care North America, Waltham, MA 02451, NDC # 49230-300-10
Quantity: 53,424 bags
Why Was This Recalled?
Lack of assurance of sterility: The product was potentially exposed to below-recommended storage temperatures, which may cause leaks in the packaging.
Where Was This Sold?
This product was distributed to 3 states: NC, SC, VA
About Fresenius Medical Care Holdings, Inc.
Fresenius Medical Care Holdings, Inc. has 161 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Drug). Last updated March 26, 2026. View original report