CORRECTING and REPLACING CAPTIONS Fresenius Kabi Issues Voluntary Nationwide Recall of 13 Lots of Ketorolac Tromethamine Injection, USP Due to the Presence of Particulate Matter in Reserve Samples

Fresenius Kabi USA, LLC is voluntarily recalling Ketorolac Tromethamine Injection, USP, 60 mg/2 mL (30 mg/mL), 2 mL fill in a 2 mL amber vial to the user level due to the presence of particulate matter. (Photo: Business Wire)

Fresenius Kabi USA, LLC is voluntarily recalling Ketorolac Tromethamine Injection, USP, 60 mg/2 mL (30 mg/mL), 2 mL fill in a 2 mL amber vial to the user level due to the presence of particulate matter. (Photo: Business Wire)

CORRECTION...by Fresenius Kabi

LAKE ZURICH, Ill.--()--Please replace the captions with the accompanying corrected captions.

The release reads:

FRESENIUS KABI ISSUES VOLUNTARY NATIONWIDE RECALL OF 13 LOTS OF KETOROLAC TROMETHAMINE INJECTION, USP DUE TO THE PRESENCE OF PARTICULATE MATTER IN RESERVE SAMPLES

Fresenius Kabi USA, LLC is voluntarily recalling 13 lots of Ketorolac Tromethamine Injection, USP, 30 mg/mL, 1 mL fill in a 2 mL amber vial and Ketorolac Tromethamine Injection, USP, 60 mg/2 mL (30 mg/mL), 2 mL fill in a 2 mL amber vial to the user level due to the presence of particulate matter composed of the following elements: carbon, silicon, oxygen and polyamides. Particulate matter was found in eight reserve sample vials.

Administration of products containing particulate matter could obstruct blood vessels and result in local irritation of blood vessels, swelling at the site of injection, a mass of tissue that could become inflamed and infected, blood clots traveling to the lung, scarring of the lung tissues, and allergic reactions that could lead to life-threatening consequences.

Ketorolac Tromethamine, a nonsteroidal anti-inflammatory drug, is indicated for the short-term (up to 5 days in adults) management of moderately severe acute pain that requires analgesia at the opioid level. The total combined duration of use of oral Ketorolac Tromethamine and Ketorolac Tromethamine injection should not exceed 5 days.

Listed below is a table of the recalled lots distributed nationwide to wholesalers, distributors, hospitals, and pharmacies between May 5, 2018 and December 16, 2019, as well as a copy of the label:

Product Name/Product size

NDC Number

Product
Code

Batch
Number

Expiration
Date

First Ship
Date

Last Ship
Date

Ketorolac Tromethamine Injection, USP, 30 mg / mL, 1 mL fill in a 2 mL amber vial

63323-162-01

160201

6118737

04/2020

05/30/2018

06/27/2018

6118902

04/2020

08/01/2018

08/15/2018

6119052

05/2020

06/25/2018

07/25/2018

6119752

08/2020

09/28/2018

12/06/2018

6122349

07/2021

09/16/2019

11/04/2019

6122538

09/2021

11/01/2019

12/16/2019

Ketorolac Tromethamine Injection, USP, 60 mg / 2 mL (30 mg / mL), 2 mL fill in a 2 mL amber vial

63323-162-02

160202

6119229

06/2020

08/09/2018

10/30/2018

6119273

06/2020

09/26/2018

03/30/2019

6119843

09/2020

11/11/2019

01/07/2020

6121115

02/2021

03/30/2019

04/22/2019

6121451

03/2021

04/29/2019

08/05/2019

6121452

03/2021

07/12/2019

10/22/2019

6121496

03/2021

06/21/2019

12/10/2019

Fresenius Kabi is notifying its distributors and customers by letter and asking customers and distributors to check their stock immediately and to quarantine and discontinue the use and distribution of any affected product. Distributors should notify their customers and direct them to quarantine and discontinue distributing or dispensing any affected lots, and to return the product to Fresenius Kabi. The recall letter and response form are available at https://www.fresenius-kabi.com/us/pharmaceutical-product-updates.

Customers with questions regarding this recall may contact Fresenius Kabi at 1-866-716-2459 Monday through Friday, during the hours of 8:00 a.m. to 5:00 p.m. Central Time. Consumers should contact their physician or health care provider if they have experienced any problems that may be related to taking or using this drug product.

Adverse reactions or quality problems experienced with the use of this product may be reported to the FDA's MedWatch Adverse Event Reporting program either online, by regular mail or by fax.

This recall is being conducted with the knowledge of the U.S. Food and Drug Administration.

About Fresenius Kabi

Fresenius Kabi (www.fresenius-kabi.com/us) is a global health care company that specializes in medicines and technologies for infusion, transfusion and clinical nutrition. The company’s products and services are used to help care for critically and chronically ill patients. The company’s U.S. headquarters is in Lake Zurich, Illinois. The company’s global headquarters is in Bad Homburg, Germany. For more information about Fresenius Kabi worldwide, please visit www.fresenius-kabi.com.

Contacts

Media contact
Matt Kuhn, (847) 550-5751
matt.kuhn@fresenius-kabi.com

Contacts

Media contact
Matt Kuhn, (847) 550-5751
matt.kuhn@fresenius-kabi.com