www.fdanews.com/articles/206930-fresenius-kabi-recalls-sodium-acetate-injection-lots
Fresenius Kabi Recalls Sodium Acetate Injection Lots
March 11, 2022
Fresenius Kabi is recalling seven lots of its sodium acetate injection, a drug that is used to prevent or correct low sodium levels in the blood, because of the presence of particulate matter found in some sample vials.
The particulates are comprised of carbon and oxygen with varying amounts of iron and trace amounts of sodium, silicon, chromium, aluminum and cellulose.
Particulate matter in injectable drugs can lead to irritation, swelling or infection, but also stroke or death due to their ability to block blood vessels, the FDA said.
The recalled lots were distributed between September 2020 and November 2021.