Fresenius Kabi USA LLC: Drug Recall

Recall #D-0651-2021 · 06/25/2021

Class II: Risk

Recall Details

Recall Number: D-0651-2021
Classification: Class II
Product Type: Drug
Recalling Firm: Fresenius Kabi USA LLC
Status: Terminated
Date Initiated: 06/25/2021
Location: Melrose Park, IL, United States
Voluntary/Mandated: Voluntary: Firm initiated
Product Quantity: 234,800 vials

Reason for Recall

Low out of specification results for epinephrine assay.

Product Description

Xylocaine-MPF with Epinephrine 1:200,000, (Lidocaine HCl and Epinephrine Injection, USP), 1%, 300 mg/30 mL, (10 mg/mL), 30 mL Single Dose Vial, 25 Vials per Tray, Rx only, Fresenius Kabi USA, LLC, Lake Zurich, IL 60047. Vial NDC 63323-487-07, Tray NDC 63323-487-37

Distribution Pattern

Distributed Nationwide in the 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.