Fresenius Kabi USA Ketorolac Tromethamine Injection, USP, 30 mg/mL - recalled due to Presence of particulate matter, USA

3 years ago •source www.fda.gov

Recall notice

Fresenius Kabi USA Ketorolac Tromethamine Injection, USP, 30 mg/mL - recalled due to Presence of particulate matter photo #1

United States

Company name: Fresenius Kabi USA
Brand name: Fresenius Kabi
Product recalled: Ketorolac Tromethamine Injection, USP, 30 mg/mL
Reason of the recall: Presence of particulate matter
FDA Recall date: January 08, 2021
Recall details: Fresenius Kabi USA is voluntarily recalling a single lot of Ketorolac Tromethamine Injection, USP, 30 mg/mL, 1 mL fill in a 2 mL amber vial to the user level due to the presence of particulate matter. Particulate matter was found in reserve sample vials. No adverse event reports have been received for the recalled lot, which was produced and sold in 2019.

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 lot distributed nationwide in the United States to wholesalers, distributors, hospitals, and pharmacies between March 28, 2019 and September 3, 2019.

Product Name/Product size: Ketorolac Tromethamine Injection, USP, 30mg / mL, 1 mL fill in a 2 mL amber vial
NDC Number: 63323-162-01
Product Code: 160201
Batch Number: 6121083
Expiration Date: 02/2021
First Ship Date: 03/28/2019
Last Ship Date: 09/03/2019

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 the affected lot, and to return the product to Fresenius Kabi.

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

Check the full recall details on www.fda.gov

Source: FDA

#drugs #recall #blood #us

306

Recent Interesting Reports

P

Online scam, Fort Pierce, FL, USA

2 weeks ago •reported by user-pxyrp196

I received a text from +1 (469) 888-8418 stating the following: I posted the text that I received. I paid $149.09 when I realized it was a scam. I reported this to the Federal Trade Commission and a couple of more sites. Just want you to be … See More
aware that this phone number is showing on my bank statement and a different number on the text.
See Less

#scam #fortpierce #florida #us

Online scam photo #1
43
X

I waited a month for the clothing I ordered, it was supposed to be a boutique, Pennsylvania, USA

1 week ago •reported by user-xyhg3663

I ordered some clothing from what I thought was a reputable store but it ended up being this horibility with chinese tracking number. Instead of clothing I received a cheap looking silver ring with a fake card saying it is moissonite. I am in Pennsylvania but the address on the box is Hillsboro OR

#gramoissaniteringscam #onlineshopping #scam #onlinescam #delivery #pennsylvania #us

I waited a month for the clothing I ordered, it was supposed to be a boutique photo #1
175
H

Unauthorized Order, Yakima, Washington, USA

2 weeks ago •reported by user-hnmpm197

04/03/24. Today in the mail, I received an unauthorized order in a package sent to me from return address Desthrrs Fottys, 3646 S Walcott Ave, Chicago Illinois. 60609. I did not place any order. I did not authorize purchase this item. I have no idea which of … See More
any of my accounts may have been charged for this item as there was no receipt with the package! What do I do?
See Less

#unorderedpackage #delivery #yakima #washington #us

Unauthorized Order photo #1
63

Create a Report

Please provide report title
Please provide location
Please provide details

Get alerts and updates for your case!

This information is not shown on the website. We can notify you of updates, and may contact you for more information to help resolve or follow up on your issue.

Please provide email or phone
Please provide email or phone

We do not show your email or contact info

Skip this step

Add photos or video

We recommend photos and videos to help explain your report

Add Photo/Video
Skip this step

Email or SMS copy of report

Enter below to get emailed a copy of your report, or sms a link to your report

Please provide email or phone
Please provide email or phone

Thank you for your report!


IMPORTANT - Your report is queued
It may take up to 12 hours to process your report.


Email us at support@safelyhq.com if you have questions.

Report by

Message us
WhatsApp
Loading...
Please provide location
Please provide location
Please provide report title
Please provide details
Please accept our Terms & Conditions
Get alerts and updates for your case! Your contact information is not shown on the website.

This information is not shown on the website. We can notify you of updates, and may contact you for more information to help resolve or follow up on your issue.

or
Please provide email or phone
Thank you for your report!

IMPORTANT - YOUR REPORT IS QUEUED - IT MAY TAKE UP TO 12 HOURS FOR YOUR REPORT TO SHOW ON OUR HOME PAGE (IF NOT OPTED AS PRIVATE)

Visit our learn pages for more helpful information or, email us: support@safelyhq.com

Goodbye! and best wishes in your recovery

Popular topics

#Lifted Boil Water Advisory #Power Outages #Boil Water Advisory #Drugs #Pet Food #Delivery #Starbucks #DreamBone Dog Treats #Online Scam #Unordered Package #Scam #First Energy #PG&E - Pacific Gas and Electric #Facebook Scam #Cedar Grove #Las Vegas
Last 30 days