Fresenius Kabi USA LLC: Drug Recall

Recall #D-0856-2021 · 09/17/2021

Class II: Risk

Recall Details

Recall Number: D-0856-2021
Classification: Class II
Product Type: Drug
Recalling Firm: Fresenius Kabi USA LLC
Status: Terminated
Date Initiated: 09/17/2021
Location: Melrose Park, IL, United States
Voluntary/Mandated: Voluntary: Firm initiated
Product Quantity: 963000 vials

Reason for Recall

Defective container: Cracked vials leading to lack of sterility assurance

Product Description

Morphine Sulfate Injection, USP, 2 mg per mL, 1 mL single dose vial, Rx only, Fresenius Kabi, Lake Zurich, IL 60047, NDC 63323-452-01. 25 vials per tray packaged 18 trays per shipper

Distribution Pattern

U.S.A. Nationwide

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.