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 CGMP Deviation: Chemical indicators were not positioned properly...
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, Rx only, Manufactured by: Fresenius Medical Care North America, Waltham, MA 02451
Quantity: 32,592 bags
Why Was This Recalled?
CGMP Deviation: Chemical indicators were not positioned properly during sterilization process.
Where Was This Sold?
Product was distributed throughout the United States.
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