Navigation Links
Bedford Laboratories™ Issues Nationwide Voluntary Recall of Cytarabine for Injection, USP, 1 Gram Per Vial
Date:2/16/2012

BEDFORD, Ohio, Feb. 16, 2012 /PRNewswire/ -- Bedford Laboratories™ announces a nationwide voluntary recall for the following three lots of Cytarabine for Injection, USP:

Cytarabine for Injection, USP 1 gram per vial – NDC #55390-133-01

  • Lot 2066986 – Exp. Date March 31, 2014
  • Lot 2111675 – Exp. Date December 31, 2013
  • Lot 2131148 – Exp. Date May 31, 2014

(Logo: http://photos.prnewswire.com/prnh/20070809/CLTH157LOGO )

This voluntary market recall is being conducted due to a post-release investigation of the manufacturing area which determined a potential elevated risk of a lack of sterility assurance for these specific lots.  To date, there have been no reports of any adverse events for the lots being recalled. 

Cytarabine in combination with other approved anticancer drugs is indicated for remission induction in acute non-lymphocytic leukemia of adults and children. It has also been found useful in the treatment of acute lymphocytic leukemia and the blast phase of chronic myelocytic leukemia. Intrathecal administration of cytarabine is indicated in the prophylaxis and treatment of meningeal leukemia.

Initial recall notification of the Cytarabine for Injection lots listed above were sent to impacted wholesalers and distributors by overnight courier and arranged for return of all recalled product.  Hospitals, emergency rooms, clinics, physician offices and other healthcare facilities and providers should not use the product lots listed above for patient care and should immediately quarantine any product for return.  Should wholesalers/distributors/retailers still have product which is being recalled, they should stop use and contact Bedford Laboratories Client Services at 800.562.4797. 

Bedford Laboratories has informed the U.S. Food and Drug Administration (FDA) of its actions and is maintaining ongoing discussion with the agency.  This voluntary recall is being conducted with the knowledge of the FDA.

Hospitals, emergency rooms, clinics, physician offices and other healthcare facilities and providers, or patients with product quality compliance, medical or other questions concerning the use of the product or reasons for this recall should contact the Client Services Department at 800.562.4797 between 8am and 5pm EST Monday - Friday.  Any adverse reactions experienced with any of the lots reported in this release should be also reported to 800.521.5169.

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.

About Bedford Laboratories
Bedford Laboratories is located in Bedford, OH and began in 1993 as a division of Ben Venue Laboratories. Bedford Laboratories supplies an extensive selection of critical-care and medically necessary multisource and specialty injectable products to the healthcare marketplace. For more information, please visit http://www.BedfordLabs.com.

About Ben Venue Laboratories, Inc.
Ben Venue Laboratories, Inc. was founded in 1938 and is a leading manufacturer of highly complex, sterile injectable drug products for the global pharmaceutical industry. Ben Venue is located in Bedford, Ohio and employs more than 1,300 people.  For more information, visit www.benvenue.com.

Ben Venue is a U.S. subsidiary of Boehringer Ingelheim Corporation (Ridgefield, CT) and a member of the Boehringer Ingelheim group of companies.  Please visit http://us.boehringer-ingelheim.com.

 


'/>"/>
SOURCE Bedford Laboratories
Copyright©2010 PR Newswire.
All rights reserved

Related medicine technology :

1. Bedford Laboratories(TM) To Begin Shipping Fluconazole Injection
2. Bedford Laboratories(TM) First To Manufacture Generic Indomethacin for Injection USP
3. Bedford Laboratories™ to Begin Shipping Dactinomycin for Injection USP 500 mcg (0.5 mg)
4. Bedford Laboratories™ to Begin Shipping Topotecan Hydrochloride for Injection, 4mg SD Vial
5. Sagard Capital Increases Ownership in GP Strategies by 350,000 Shares in a Private Transaction with Bedford Oak Partners, L.P.
6. Bedford Laboratories™ Issues Guidance on 2011 Voluntary Recall of Polymyxin B for Injection USP and Vecuronium Bromide for Injection Related to Glass Particulates
7. The First Annual Cervical Cancer/HPV Conference Tackles Controversial Vaccine Issues and Encourages Advocacy
8. European Unions CHMP Issues Positive Opinion on PEGINTRON(TM) Combination Therapy for Retreating Hepatitis C Patients Who Failed Previous Therapy
9. European CHMP Issues Positive Opinion for ATRIPLA(R) (efavirenz 600 mg/ emtricitabine 200 mg/tenofovir disoproxil fumarate 300 mg)
10. Bayer Issues Additional Guidance to Physicians on Trasylol(R)
11. Crystal Research Associates, LLC Issues Executive Informational Overview(R) (EIO(R)) on CEL-SCI Corporation
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:6/23/2016)... , June 23, 2016 Research ... MEMS Devices Medical Market Analysis 2016 - Forecast to 2022" ... The report contains up to date financial data ... analysis. Assessment of major trends with potential impact on the ... analysis of market segmentation which comprises of sub markets, regional ...
(Date:6/23/2016)... , June 23, 2016 , ... on Thursday, July 7, 2016 , , , , LOCATION: ... , , , , EXPERT PANELISTS:  , , , ... Senior Industry Analyst, Christi Bird; Senior Industry Analyst, Divyaa Ravishankar and ... The global pharmaceutical industry is witnessing an exceptional era. ...
(Date:6/23/2016)...  Guerbet announced today that it has been named ... . One of 12 suppliers to receive ... support of Premier members through exceptional local customer service ... to lower costs. ... outstanding customer service from Premier," says Massimo Carrara ...
Breaking Medicine Technology:
(Date:6/24/2016)... ... ... Marcy was in a crisis. Her son James, eight, was out of control. Prone to ... , “When something upset him, he couldn’t control his emotions,” remembers Marcy. “If there ... my other children and say he was going to kill them. If we were ...
(Date:6/24/2016)... ... June 24, 2016 , ... Global law firm Greenberg Traurig, P.A. announced that ... chosen by their peers for this recognition are considered among the top 2 percent ... special honors as members of this year’s Legal Elite Hall of Fame: Miami ...
(Date:6/24/2016)... ... June 24, 2016 , ... Comfort Keepers® of San Diego, ... and the Road To Recovery® program to drive cancer patients to and from their ... to ensure the highest quality of life and ongoing independence. Getting to and ...
(Date:6/24/2016)... ... June 24, 2016 , ... People across the U.S. are sharpening their pencils ... an essay contest in which patients and their families pay tribute to a genetic ... 2016 National Society of Genetic Counselors (NSGC) Annual Education Conference (AEC) this September. ...
(Date:6/24/2016)... York, NY (PRWEB) , ... June 24, 2016 ... ... publication Haute Living, is proud to recognize Dr. Barry M. Weintraub as a ... that “the most beautiful women in the world, and the most handsome men, ...
Breaking Medicine News(10 mins):