Navigation Links
Bedford Laboratories™ Issues Guidance on 2011 Voluntary Recall of Polymyxin B for Injection USP and Vecuronium Bromide for Injection Related to Glass Particulates
Date:1/10/2012

BEDFORD, Ohio, Jan. 10, 2012  /PRNewswire/ -- Bedford Laboratories™ today issued updated guidance on the following nationwide voluntary product recalls originally issued on August 2, 2011:

  • Polymyxin B for Injection USP, 500,000 Units per vial – NDC #55390-139-10
    Lot 1942980 – Exp. Date August 2013 and Lot 1895027 – Exp. Date June 2013
  • Vecuronium Bromide for Injection, 10 mg per vial – NDC #55390-037-10
    Lot 1865067 – Exp. Date May 2012
  • Vecuronium Bromide for Injection, 20 mg per vial – NDC #55390-039-10
    Lot 1865069 – Exp. Date February 2012

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

The recalls were initiated on August 2, 2011 after the discovery of a visible glass particle in a limited number of vials within the lots listed above to the user level.   

Particulate matter in injections can be harmful when introduced into the bloodstream.  Potential adverse events after intravenous administration may include vein irritation and phlebitis, pulmonary dysfunction and granulomas, local tissue infarction, occlusion of capillaries and arteries, anaphylactic shock, and death.  The introduction of particulate matter via the intrathecal route into the cerebrospinal fluid may serve as a nidus for the development of chemical meningitis.  Introduction of a foreign body to the eye via topical or subconjuntive routes can cause corneal abrasion/laceration, lacrimal tear and general irritation.  To date, there have been no reports of adverse events for the lots being recalled.

Polymyxin B is indicated in the treatment of acute infections caused by susceptible strains of Pseudomonas aeruginosa. Polymyxin B sulfate is a drug of choice in the treatment of infections of the urinary tract, meninges, and bloodstream caused by susceptible strains of Ps. aeruginosa. It may also be used topically and subconjunctivally in the treatment of infections of the eye caused by susceptible strains of Ps. aeruginosa.

Vecuronium Bromide is indicated as an adjunct to general anesthesia, to facilitate endotracheal intubation and to provide skeletal muscle relaxation during surgery or mechanical ventilation.

Initial recall notification of the Polymyxin B for Injection and Vecuronium Bromide for Injection lots listed above were sent to impacted wholesalers and distributors on August 2, 2011 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 Professional Services Department at 800.521.5169.  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.

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

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. The First Annual Cervical Cancer/HPV Conference Tackles Controversial Vaccine Issues and Encourages Advocacy
7. European Unions CHMP Issues Positive Opinion on PEGINTRON(TM) Combination Therapy for Retreating Hepatitis C Patients Who Failed Previous Therapy
8. European CHMP Issues Positive Opinion for ATRIPLA(R) (efavirenz 600 mg/ emtricitabine 200 mg/tenofovir disoproxil fumarate 300 mg)
9. Bayer Issues Additional Guidance to Physicians on Trasylol(R)
10. Crystal Research Associates, LLC Issues Executive Informational Overview(R) (EIO(R)) on CEL-SCI Corporation
11. QIAGEN and Center for Molecular Medicine Create Research Collaboration for Molecular Diagnostic Markers for Breast Cancer, Other Womens Health Issues
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:10/12/2017)... 2017   Divoti USA will engrave and ... standard of the latest FDA requirements, which stipulates new criteria regarding ... in need of Medical ID jewelry such as Medical ID Bracelets, ... engraved in terms of the new FDA requirements . ... Divoti offers this dark mark fiber ...
(Date:10/11/2017)... , Oct. 11, 2017  Hill-Rom Holdings, Inc. ... Aspen Surgical facility in Las Piedras, Puerto ... scalpels and blades. ... that the facility sustained minor structural damage, temporary loss ... Maria. Repairs have been completed, manufacturing operations have resumed, ...
(Date:10/4/2017)... South Korea , Oct. 4, 2017  South ... its next-generation CPR training aide "cprCUBE" on Kickstarter. The ... chest compression during cardiac arrests with better efficiency compared ... It also offers real-time feedback on efficacy of the ... The crowdfunding campaign has a goal to raise $5,000. ...
Breaking Medicine Technology:
(Date:10/13/2017)... ... October 13, 2017 , ... ... Randall, PharmD ‘17, and Jennifer Huggins, PharmD ’17, along with clinical associate ... primary prevention of cardiovascular diseases during the 15th Annual Women’s Health Conference. ...
(Date:10/13/2017)... ... 13, 2017 , ... The Visiting Nurse Association (VNA) of Somerset Hills is ... vendors and unique items from across the nation, this holiday-themed event will raise funds ... by the VNA. The boutique will be open Saturday, November 4 (10:00 a.m. ...
(Date:10/13/2017)... (PRWEB) , ... October 13, 2017 , ... ... will be giving viewers the lowdown on sciatica in a new episode of ... that focuses on current events and innovation and investigates each subject in-depth with ...
(Date:10/12/2017)... ... October 12, 2017 , ... First Healthcare ... program management, will showcase a range of technology and learning solutions at the ... Convention and Expo to be held October 14–18, 2017 at the Mandalay Bay ...
(Date:10/12/2017)... ... 2017 , ... IsoComforter, Inc. ( https://isocomforter.com ), one of the ... new design of the shoulder pad. The shoulder pad provides optimal support and ... pain while using cold therapy. By utilizing ice and water that is circulated from ...
Breaking Medicine News(10 mins):