Safety Report: Fresenius Kabi Sodium Acetate Injection, USP - recalled due to Particulate Matter, USA

United States

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. Sodium Acetate Injection, USP 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 is also useful as an additive for preparing specific IV fluid formulas when the needs of the patient cannot be met by standard electrolyte or nutrient solutions.

Listed below is a table of the recalled lots distributed nationwide to wholesalers, distributors, hospitals, and pharmacies between September 2020 and November 2021.

Company name: Fresenius Kabi, USA
Brand name: Fresenius Kabi USA
Product recalled: Sodium Acetate Injection, USP, 400 mEq/100 mL (4 mEq/mL), 100 mL fill in a 100 mL vial
Reason of the recall: Due to the presence of particulate matter found in reserve and/or stability sample vials
FDA Recall date: March 07, 2022

Check the full recall details on www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/fresenius-kabi-issues-voluntary-recall-sodium-acetate-injection-usp-due-presence-particulate-matter

Source: FDA