Fresenius Kabi USA, LLC: Drug Recall

Recall #D-0245-2021 · 12/23/2020

Class I: Dangerous

Recall Details

Recall Number: D-0245-2021
Classification: Class I
Product Type: Drug
Recalling Firm: Fresenius Kabi USA, LLC
Status: Terminated
Date Initiated: 12/23/2020
Location: Lake Zurich, IL, United States
Voluntary/Mandated: Voluntary: Firm initiated
Product Quantity: 945,425 vials

Reason for Recall

Presence of Particulate Matter - found in reserve sample vials at the firm.

Product Description

Ketorolac Tromethamine Injection, USP, 30 mg per mL, packaged in 1 mL Single Dose Vials (NDC 63323-162-00); 25 x 1 mL Single Dose Vials per tray (NDC 63323-162-01); For IM or IV use, Rx only, Fresenius Kabi, Lake Zurich, IL 60047.

Distribution Pattern

Nationwide USA and Puerto Rico

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.