Company Announcement Date: April 20, 2020

FDA Publish Date: April 20, 2020

Product Type: Drugs

Reason for Announcement: Presence of Particulate Matter

Company Name: Fresenius Kabi USA, LLC

Brand Name: Fresenius Kabi

Product Description: Ketorolac Tromethamine Injection, USP, 30 mg/mL, and Ketorolac Tromethamine Injection, USP, 60 mg/2 mL

Company Announcement Date: April 20, 2020

FDA Publish Date: April 20, 2020

Product Type: Drugs

Reason for Announcement: Presence of Particulate Matter

Company Name: Fresenius Kabi USA, LLC

Brand Name: Fresenius Kabi

Product Description: Ketorolac Tromethamine Injection, USP, 30 mg/mL, and Ketorolac Tromethamine Injection, USP, 60 mg/2 mL/nSummary

Company Announcement

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 shortterm (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.

Complete and submit the report Online

Regular Mail or Fax: Download form or call 1- 800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178

Or, contact Fresenius Kabi at 1-800-551-7176, Monday through Friday, during the hours of 8:00 a.m. to 5:00 p.m. or via email at: productcomplaint.USA@fresenius-kabi.com or adverse.events.USA@fresenius-kabi.com

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