Navigation Links
American Regent Expands Voluntary Recall to Include All Lots of Ketorolac Tromethamine Injection, USP 15 mg/mL; 1mL Single Dose Vials
Date:11/3/2009

SHIRLEY, N.Y., Nov. 3 /PRNewswire/ -- American Regent conducts nationwide voluntary recall of ALL lots of its Ketorolac Tromethamine Injection, USP 15 mg/mL:

            NDC# 0517-0601-25     15 mg/mL       1mL Single Dose Vial

PLEASE NOTE: This recall is in addition to the voluntary recall initiated on October 16, 2009 when American Regent voluntarily recalled ALL unexpired lots of Ketorolac Tromethamine Injection, USP, 30 mg/mL due to the presence of particulate matter in conjunction with crystallization.

This voluntary recall is due to the potential that particulates from crystallization may be present in the product. American Regent is undertaking this recall in consideration of the potential for safety issues if the product is administered to patients, including obstruction of blood vessels which can induce pulmonary emboli or thrombosis, activate platelets and/or neutrophils to induce anaphylactic reactions. Other adverse effects associated with the injection of particulate matter include foreign body granulomas, and local irritation at the injection site.

The product was distributed to wholesalers and distributors nationwide.

Hospitals, surgi-centers, clinics and other healthcare facilities should not use any AMERICAN REGENT Ketorolac Tromethamine Injection, USP Injection 15 mg/mL for patient care and should immediately quarantine any product for return.

"Patient safety is our primary concern, and we are committed to taking the necessary steps to protect patients from any potential safety risks as we continue to investigate this issue," said Mary Jane Helenek, President and CEO of American Regent.

While American Regent continues to investigate this issue, the company is taking precautionary action and initiated this voluntary recall. American Regent has informed the FDA of its actions and is maintaining ongoing discussions with the Agency.

As is standard practice, and as stated in the Ketorolac Tromethamine Injection Product Package Insert, "Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration whenever solution and container permit."

American Regent will credit accounts for all returned Ketorolac Tromethamine Injection, USP product. Those with questions about the return process, please call our Customer Service Department at 1-800-645-1706: Monday thru Friday from 8:30 AM to 7:00 PM ET.

Hospitals, surgi-centers, clinics and healthcare providers, or patients with other questions may contact the Professional Services Department at 631-924-4000.

Any adverse reactions experienced with the use of this product, and/or quality problems should be reported to American Regent, Inc. via email at PV@luitpold.com, by fax to 610-650-7781 or 610-650-0170 or by phone at 1-800-734-9236. Adverse reactions may also be reported to FDA's MedWatch Adverse Event Reporting program online, or by returning the postage paid FDA form 3500, by mail to [MedWatch, 5600 Fishers Lane, Rockville, MD 20852-9787] or via fax [1-800-FDA-0178].

Ketorolac Tromethamine Injection, USP is manufactured by Luitpold Pharmaceuticals, Inc. and is distributed by American Regent, Inc. (Shirley, NY).

SOURCE Luitpold Pharmaceuticals, Inc.


'/>"/>
SOURCE Luitpold Pharmaceuticals, Inc.
Copyright©2009 PR Newswire.
All rights reserved

Related medicine technology :

1. Educational Video Series Released for American Diabetes Month
2. CyberKnife to be Focus of Numerous Presentations at the American Society for Radiation Oncology (ASTRO) Annual Meeting
3. Consumer Reports Health: Americans With Heartburn Paying Too Much Green For Nexiums Purple Pill
4. Atherotech to Exhibit VAP(R) Cholesterol Test at American Heart Association Scientific Sessions 2009
5. Bayer and Onyx Announce Nexavar Data Presentations at 60th American Association for the Study of Liver Diseases Annual Meeting
6. Confusion over Influenzinum Clarified by the American Association of Homeopathic Pharmacists (AAHP)
7. American Association for Homecare Proposes Strong Anti-Fraud Measures in Medicare, Applauds HHS Testimony Today That Pledges to "Stop Fraud Before it Starts"
8. American Lung Association of California Joins Sheriffs Department to Support Influenza Vaccination In Sacramento
9. Phase 2 Data From Oral NKTR-118 Presented at American College of Gastroenterology in San Diego
10. Lumenis Introduces Advanced Retinal Laser Delivery Technology at the 2009 American Academy of Ophthalmology Annual Meeting in San Francisco, California, USA
11. National Pharmacy Technician Day: Pharmacy Technician Certification Board (PTCB) Recognizes Pharmacy Technicians During Octobers American Pharmacists Month
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:6/24/2016)... DUBLIN , June 24, 2016 ... addition of the "Structural Electronics 2015-2025: Applications, ... In-Mold Electronics, Smart ... Integrated Photovoltaics Structural electronics involves ... as load-bearing, protective structures, replacing dumb structures such ...
(Date:6/24/2016)... According to a new market ... Needles, Safety Pen Needles), Needle Length (4mm, 5mm, 6mm, ... of Purchase (Retail, Non-Retail) - Trends & Global Forecasts ... market for the forecast period of 2016 to 2021. ... by 2021 from USD 1.65 Billion in 2016, growing ...
(Date:6/23/2016)... , June 23, 2016 Research and ... Global Market - Forecast to 2022" report to their ... treatment method for the patients with kidney failure, it replaces ... fluid from the patient,s blood and thus the treatment helps ... and chloride in balance. Increasing number of ...
Breaking Medicine Technology:
(Date:6/26/2016)... (PRWEB) , ... June 26, 2016 , ... Pixel Film ... Pro X. , "Film editors can give their videos a whole new perspective by ... Austin - CEO of Pixel Film Studios. , ProSlice Levels contains over 30 ...
(Date:6/26/2016)... ... , ... Brent Kasmer, a legally blind and certified personal trainer is helping to develop a ... fitness app plans to fix the two major problems leading the fitness industry today:, ... type program , They don’t eliminate all the reasons people quit their exercise ...
(Date:6/25/2016)... ... 25, 2016 , ... Experts from the American Institutes for ... Meeting June 26-28, 2016, at the Hynes Convention Center in Boston. , AIR ... care planning, healthcare costs and patient and family engagement. , AIR researchers will ...
(Date:6/25/2016)... ... June 25, 2016 , ... The temporary closing of Bruton Memorial Library on June 21 due ... up a new, often overlooked aspect of head lice: the parasite’s ability to live away ... a common occurrence, but a necessary one in the event that lice have simply gotten ...
(Date:6/25/2016)... , ... June 25, 2016 , ... First Choice ... States, named Dr. Sesan Ogunleye, as the Medical Director of its new Mesquite-Samuell Farm ... Medical Director of our new Mesquite location,” said Dr. James M. Muzzarelli, Executive Medical ...
Breaking Medicine News(10 mins):