Fresenius Kabi USA, LLC: Drug Recall

Recall #D-0750-2022 · 03/04/2022

Class I: Dangerous

Recall Details

Recall Number: D-0750-2022
Classification: Class I
Product Type: Drug
Recalling Firm: Fresenius Kabi USA, LLC
Status: Terminated
Date Initiated: 03/04/2022
Location: Lake Zurich, IL, United States
Voluntary/Mandated: Voluntary: Firm initiated
Product Quantity: 118,040 vials

Reason for Recall

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 Description

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

Distribution Pattern

Nationwide USA

Other Recalls by Fresenius Kabi USA, LLC

Class II: Risk 11/21/2025

Emphasizing instructions for LVP duration programming located in the IFU.
Class I: Dangerous 11/14/2025

Software version 5.10.1 and earlier contain anomalies that have the potential to cause serious patient harm or death.
Class I: Dangerous 11/06/2025

Microbial Contamination of Sterile Products; out of limit results obtained for endotoxin testing.
Class II: Risk 11/03/2025

Downstream Occlusion alarms may occur during procedures using low flow infusion rates when a check valve* is added to the Ivenix Administration Set.
Class I: Dangerous 11/03/2025

Incorrect assembly of specific lot of LVP Primary Administration Set that could result in serious patient injury.

View all recalls by Fresenius Kabi USA, LLC →

Data from FDA openFDA enforcement reports. This site is not affiliated with or endorsed by the FDA. Recall information may be updated by the FDA at any time.