Fresenius Kabi USA announced today that it initiated the voluntary recall of seven lots of its sodium acetate injection.
Lake Zurich, Illinois-based Fresenius Kabi recalled the USP, 400 mEq/100 mL (4 mEq/mL), 100 mL fill in a 100 mL vial to the user level due to the presence of particulate matter found in reserve and/or stability sample vials.
According to a news release, microscopic and elemental analyses determined the presence of particulates composed of carbon and oxygen with varying amounts of iron and trace amounts of sodium, silicon, chromium, aluminum and cellulose. The administration of an injectable product containing such particulate matter may result in local irritation or swelling or infection in response to the foreign material.
If the particulate matter reaches the blood vessels, it can travel to various organs and block blood vessels in the heart, lungs or brain, potentially causing stroke and possibly leading to death. To date, Fresenius Kabi has received no adverse event reports for the recalled lots, which were produced and sold in 2020 and 2021.
The company’s sodium acetate injection is indicated as a source of sodium for addition to large-volume IV fluids to prevent or correct low blood-sodium levels in patients with restricted or no oral intake. It can also be used as an additive for preparing specific IV fluid formulas when the needs of a patient can’t be met by standard electrolyte or nutrient solutions.
Fresenius Kabi asked customers and distributors to check their stock immediately and to quarantine and discontinue the use and distribution of affected products. The company is conducting the recall with the knowledge of the FDA.