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:2/23/2017)... , Feb 23, 2017 Research and Markets ... Price Analysis and Strategies - 2016" report to their offering. ... The latest ... provides drug pricing data and benchmarks in the global Autism Spectrum ... What are the key drugs marketed for Autism ...
(Date:2/23/2017)... ITL Limited, ( ASX: ITD ), an innovative diversified ... year ended 31 December 2016 compared with the previous corresponding period. ... viewed here . Highlights ... Earnings per share of 2.2 cents (Dec 2015: ... 2015: $15.7m; up 11%) Profit before tax of ...
(Date:2/23/2017)... -- Research and Markets has announced the addition of ... report to their offering. ... The latest research Oesophageal Cancer Drugs Price Analysis ... the global Oesophageal Cancer market. The research answers the ... drugs marketed for Oesophageal Cancer and their clinical attributes? How are ...
Breaking Medicine Technology:
(Date:2/24/2017)... ... 24, 2017 , ... Healthcare Associates of McKinney announced today that ... at 8080 State Highway 121, Suite 210, McKinney, Texas 75070. It is in ... , As the practice has grown, the need for more space has been paramount. ...
(Date:2/24/2017)... ... February 24, 2017 , ... The International Association of Eating Disorders Professionals ... What You See” body image mannequin art competition. Selected from 15 submissions from around ... winner revealed at the 31st annual iaedp Symposium, March 22 – 26 in Las ...
(Date:2/24/2017)... Charlevoix, MI (PRWEB) , ... February 24, 2017 ... ... venue in Charlevoix, once again hosted their Military Wedding Giveaway, with the ... be hosted by Castle Farms with services generously donated from local vendors: A ...
(Date:2/23/2017)... ... February 23, 2017 , ... Rare ... audience, will be participating in Rare Disease Day events, hosted by the Rare ... Rare Disease Report, a website, weekly e-newsletter and quarterly publication, will be conducting ...
(Date:2/23/2017)... (PRWEB) , ... February 23, 2017 , ... ... an approved content provider for the National Institute for Health and Care ... social care-related organizations in the National Health Service (NHS) to search, order and ...
Breaking Medicine News(10 mins):