Fresenius Kabi issued a voluntary recall of seven lots of sodium acetate intravenous fluid after testing found particulates of carbon and oxygen with traces of sodium, silicon, chromium, aluminum and cellulose.
Sodium acetate injection is used to correct low blood sodium levels in patients who have restricted or no oral intake. It’s also used as an additive for preparing specific IV fluid formulas when patients cannot take standard electrolyte or nutrient solutions.
The voluntary recall covers 400-mEq/100-mL (4-mEq/mL) vials that were distributed across the U.S. to wholesalers, distributors, hospitals and pharmacies between September 2020 and November 2021.
Fresenius Kabi hadn’t received any side effect reports by the time it issued the voluntary recall on Monday. Use of the potentially tainted product could result in local irritation, swelling or infection. If the particulate matter reaches blood vessels, it can travel to various organs and block blood vessels in the heart, lungs or brain, which could cause stroke and even death.
RELATED: Fresenius Kabi pulls anti-inflammation drug Ketorolac over particulate fears—again
The German drugmaker has had several manufacturing hiccups in recent years. Just over a year ago, the company pulled one lot of its anti-inflammatory drug ketorolac tromethamine after particulates turned up in sample vials on reserve. That recall came just seven months after Fresenius Kabi initiated a voluntary recall of 13 lots of the same drug after particulates made of carbon, silicon, oxygen and polyamide were found in eight vials of the drug.
The company experienced additional recalls in 2020 that included BeiGene’s cancer med Abraxane along with two separate recalls of injectable dexmedetomidine hydrochloride, a powerful sedative used to put and keep patients under during surgery, after the company found lidocaine cross-contamination.