Fresenius Kabi USA is voluntarily recalling seven lots of Sodium Acetate Injection, 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. 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 that contains 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 which can cause stroke and even lead to death. To date, no adverse event reports have been received for these recalled lots, which were produced and sold in 2020 and 2021.