Fresenius Kabi USA, LLC is recalling 118,040 vials of Sodium Acetate Injection, USP (400 mEq / 100 mL). The recall was initiated after the discovery of particulate matter in the medication, which contains elements like carbon, oxygen, iron, and trace amounts of minerals and cellulose. This product is a prescription medication primarily distributed to hospitals, pharmacies, and healthcare facilities nationwide. No injuries or adverse incidents have been reported to date.
Injecting a medication containing particulate matter can cause serious health issues, including local inflammation, the formation of granulomas, or the blockage of blood vessels, which could lead to complications in various organs. The risk is particularly high for patients receiving medication through intravenous infusion.
Packaged in 2 trays of 20 vials per shipper.
Fresenius Kabi USA, Sodium Acetate Injection, USP, 400 mEq/100 mL (4 mEq/mL), 100 mL fill in a 100 mL vial
If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.
This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.
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Sources: FDA iRES · FDA Press Release · Raw API Response
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