Navigation Links
American Regent Initiates Nationwide Voluntary Recall of Caffeine & Sodium Benzoate Injection, USP 250 mg/mL, 2 mL Single Dose Vial Due to Visible Particulates
Date:5/5/2011

SHIRLEY, N.Y., May 5, 2011 /PRNewswire/ -- American Regent is conducting a nationwide voluntary recall to the consumer and user level of the following product:

Caffeine & Sodium Benzoate Injection, USP, 250 mg/mL, 2 mL Single Dose Vial,
NDC # 0517-2502-10, Lot # 0084,  Exp Date  February, 2012

PLEASE NOTE:  This recall, initiated on May 5, 2011 to the User or Consumer Level, is for Lot # 0084 Only.  No other lots of Caffeine & Sodium Benzoate Injection, USP are subject to this voluntary recall.

This voluntary recall was initiated because some of the vials of this lot may contain visible particulates. Potential adverse events after intravenous administration of solutions containing particulates may include disruption of blood flow within small blood vessels in the lung, localized inflammation (swelling and redness), and granuloma formation. Intramuscular administration could result in foreign body inflammatory response, with local pain, swelling and possible long term granuloma formation. American Regent is undertaking this voluntary recall in consideration of the potential for safety issues, if this lot of Caffeine & Sodium Benzoate Injection, USP is administered to patients.

Caffeine and Sodium Benzoate Injection has been used in conjunction with supportive measure to treat respiratory depression associated with overdosage with CNS depressant drugs (e.g., narcotic analgesics, alcohol).  However, because of questionable benefit and transient action, most authorities believe caffeine and other analeptics should not be used in these conditions and recommend other supportive therapy.

The product was distributed to wholesalers and distributors nationwide.

Hospitals, Emergency Rooms, Clinics and other healthcare facilities should not use American Regent Inc., Caffeine & Sodium Benzoate Injection, USP, 250 mg/mL, 2 mL Single Dose Vials with Lot # 0084 for patient care and should immediately quarantine any product for return.

American Regent is notifying its distributors and consumers by email, facsimile and/or overnight courier and is arranging for return of all recalled product.  Consumers/distributors/retailers that have product which is being recalled should stop use.

American Regent will credit accounts for all returned product with this lot #. Those with questions about the return or recall process, please call our Customer Service Department at 1-877-788-3232: Monday thru Friday from 8:30AM to 7:00PM EDT.

Hospitals, emergency rooms, clinics and healthcare providers, or patients with product quality complaints, medical or other questions concerning the use of the product or reasons for this recall should contact the Professional Services Department at 1-877-788-3232.

Any adverse reactions experienced with the use of this product should be reported to American Regent, Inc. via email at pv@luitpold.com by fax to (610) 650-0170 or by phone at 1-800-734-9236.  TO EXPEDITE HANDLING PLEASE DO NOT REPORT ANYTHING OTHER THAN SPECIFIC ADVERSE EVENTS TO THIS EMAIL ADDRESS OR FAX OR PHONE.

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


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 Caffeine & Sodium Benzoate Injection, USP, Product Package Insert, "Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit."

Caffeine & Sodium Benzoate Injection, USP is manufactured by Luitpold Pharmaceuticals, Inc. and is distributed by American Regent, Inc. (Shirley, NY).

Source: Luitpold Pharmaceuticals, Inc.

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


'/>"/>
SOURCE Luitpold Pharmaceuticals, Inc.
Copyright©2010 PR Newswire.
All rights reserved

Related medicine technology :

1. American Pacific to Release Financial Results and Hold Fiscal 2011 Second Quarter Investor Teleconference
2. American Medical Systems GreenLight HPS® Approved for Use in Japan
3. Christiana Care Breast Center First in Delaware to Earn American College of Radiology Accreditation
4. Plato BioPharma Presenting Poster at the American Thoracic Society Conference
5. Hologic Features New Minimally Invasive Technologies at the American Congress of Obstetricians and Gynecologists Annual Meeting
6. Reportlinker Adds Latin American Markets for Dental Implants, Final Abutments and Computer Guided Surgery 2011 (Argentina, Brazil and Mexico)
7. American Regent Resumes Shipment of VENOFER® (iron sucrose injection, USP)
8. May is Older Americans Month
9. Nonin Medical Announces Mark VanderWerf, Vice President-eHealth, Elected to American Telemedicine Association College of Fellows
10. Pearl Therapeutics to Present Complete PT003 Results from Phase 2b COPD Study in a Late-Breaker Session at the American Thoracic Society Annual Meeting
11. CVS Caremark to Complete Acquisition of Universal Americans Medicare Part D Business
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:2/16/2017)... Feb. 16, 2017 Research and Markets ... Emerging Medical Device Technologies" report to their offering. ... Traditional ... procedures, general instruments, non-drug coated implantables, large endoscopes, needle based ... use over the last two to three decades for the ...
(Date:2/16/2017)... Ontario , Feb. 16, 2017  Aralez Pharmaceuticals ... global specialty pharmaceutical company, today announced that executive management ... Conference to be held February 22-23, 2017. Adrian ... of the Company at 1:35 p.m. local time on ... and audio archive for the event may be accessed ...
(Date:2/16/2017)... , Feb. 16, 2017  AcelRx Pharmaceuticals, ... pharmaceutical company focused on the development and commercialization ... acute pain, announced that Vincent J. Angotti ... a member of the company,s board of directors, ... over two decades of experience leading executive and ...
Breaking Medicine Technology:
(Date:2/18/2017)... CA (PRWEB) , ... February 18, 2017 , ... ... paragraph presets. Use Pixel Film Studios ’ ProParagraph Fashion Volume 2 ... and so many other applications. Users can pick and choose from hand-crafted ...
(Date:2/17/2017)... Davidson, NC (PRWEB) , ... February 17, 2017 , ... ... Davidson Commons Shopping Center in Davidson, NC. Dr. Brian Seese leads the practice as ... of dental services under one roof. Smiles by Seese serves patients of all ages ...
(Date:2/17/2017)... ... February 17, 2017 , ... The Alliance Healthcare ... designed to further positively impact the health and wellness of our community in ... it our duty to seriously consider releasing our assets beyond our 5% targeted ...
(Date:2/17/2017)... Nashville, TN (PRWEB) , ... February 17, 2017 ... ... Services, Inc. (ISTS) brings its educational assistance management solution to the exhibit floor ... Convention Center in Orlando, Fla. , From Feb. 19–23, 2017, more than ...
(Date:2/17/2017)... Verdes, CA (PRWEB) , ... February 17, 2017 ... ... emotional flow is Dr. Carol Francis' goals for each and every ... Conference, Dr. Carol Francis will demonstrate five different brainwave tools which help energize ...
Breaking Medicine News(10 mins):