Fresenius Kabi Recalls Sodium Acetate Injection


Fresenius Kabi USA is recalling seven lots of Sodium Acetate Injection, USP to the user level due to the presence of particulate matter, the US. Food and Drug Administration said.

The recall involves Sodium Acetate Injection, USP 400 mEq/100 mL (4 mEq/mL), 100 mL fill in a 100 mL vial.

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.

The recalled lots were distributed across the United States to wholesalers, distributors, hospitals, and pharmacies between September 2020 and November 2021.

The recall was initiated after the presence of particulate matter was found in reserve and/or stability sample vials.

The agency noted that 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. The particulate matter, if reaches the blood vessels, can travel to various organs and block blood vessels in the heart, lungs or brain that can cause stroke and even death.

However, the company has not received any adverse event reports for the recalled lots, which were produced and sold in 2020 and 2021, to date.

Distributors and customers are asked to return the affected product to Fresenius Kabi.

In similar recalls, AuroMedics Pharma LLC in late Jnauary called back certain Polymyxin B for Injection USP, 500,000 Units/Vial to the consumer level in the United States citing the possible presence of particulate matter, identified as hair.

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