Fresenius Kabi USA, LLC recalls Sodium Acetate Injection, USP, 400 mEq / 100 mL (4 mEq / mL), packaged in 2 trays of 20 vials per shipper (NDC 63323-032

Recalled March 30, 2022 · FDA recall D-0750-2022 · Fresenius Kabi USA

Hazard

Presence of particulate matter: particulates composed of carbon and oxygen with varying amounts of iron and trace amounts of sodium, silicon, chromium, aluminum and cellulose. · FDA Class I

Units

118,040 vials

Sold at

Nationwide USA

Description

Presence of particulate matter: particulates composed of carbon and oxygen with varying amounts of iron and trace amounts of sodium, silicon, chromium, aluminum and cellulose.

Product

Sodium Acetate Injection, USP, 400 mEq / 100 mL (4 mEq / mL), packaged in 2 trays of 20 vials per shipper (NDC 63323-032-00), each vial: 100 mL fill in a 100 mL vial (NDC 63323-032-04), Rx Only, Fresenius Kabi, Lake Zurich, IL 60047

Manufacturer(s)

Fresenius Kabi USA, LLC

Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →