The lots could contain trace amounts of sodium, silicon, chromium, aluminum, and cellulose, which could result in irritation or infection and has the potential to block blood vessels in the heart, lungs, or brain.
Fresenius Kabi USA is voluntarily recalling seven lots of sodium acetate injection, 400 mEq/100 mL because of the presence of particulates. Analyses have indicated the presence of carbon and oxygen with varying amounts of iron and trace amounts of sodium, silicon, chromium, aluminum, and cellulose.
This can result in local irritation, swelling, or infection. If the particulate matter reaches the blood vessels, it can travel to various organs and block blood vessels in the heart, lungs or brain, which can cause stroke and even lead to death.
Company officials say there have been no adverse events reported.
Sodium acetate is indicated as a source of sodium, for addition to large volume IV fluids to prevent, or to correct low blood sodium levels. The seven lots were produced and sold in 2020 and 2021. The lots involved are listed here.