BioSpace Collaborative

Academic/Biomedical Research
News & Jobs
Biotechnology and Pharmaceutical Channel Medical Device and Diagnostics Channel Clinical Research Channel BioSpace Collaborative    Job Seekers:  Register | Login          Employers:  Register | Login  

NEWSLETTERS
Free Newsletters
Archive
My Subscriptions

NEWS
News by Subject
News by Disease
News by Date
PLoS
Search News
Post Your News
JoVE

CAREER NETWORK
Job Seeker Login
Most Recent Jobs
Search Jobs
Post Resume
Career Fairs
Career Resources
For Employers

HOTBEDS
Regional News
US & Canada
  Biotech Bay
  Biotech Beach
  Genetown
  Pharm Country
  BioCapital
  BioMidwest
  Bio NC
  BioForest
  Southern Pharm
  BioCanada East
  C2C Services & Suppliers™
Europe
Asia

DIVERSITY

PROFILES
Company Profiles

INTELLIGENCE
Research Store

INDUSTRY EVENTS
Research Events
Post an Event
RESOURCES
Real Estate
Business Opportunities

 News | News By Subject | News by Disease News By Date | Search News
Get Our Industry eNewsletter FREE email:    
   

Bedford Laboratories Issues a Voluntary Nationwide Patient Level Recall of Acetylcysteine Solution, USP, Lot 1877093


2/2/2012 10:51:17 AM

BEDFORD, Ohio, Feb. 2, 2012 /PRNewswire/ -- Bedford Laboratories, today issues updated guidance on the following nationwide voluntary product recall originally initiated on December 20, 2011:

Acetylcysteine Solution, USP, (Manufactured for Roxane Laboratories, Inc.)
20%, 30 mL per vial NDC #0054-3026-02 Lot 1877093 Exp. Date June 2013

This voluntary recall was initiated on December 20, 2011 after the discovery of a single visible glass particle in a vial within the lot listed above. There have been no complaints or adverse events related to a piece of glass in vials of this lot. All other product parameters were within specifications.

Acetylcysteine for inhalation is usually delivered via a Nebulizer, but can also be delivered via direct instillation into a tracheostomy, or into the bronchial-pulmonary tree during bronchosopy. Glass particles can cause airway obstruction resulting in symptoms of choking, wheezing, difficulty breathing, coughing and potentially hemoptysis. Use of an inhaled product with glass particles has the potential to cause choking which could be life-threatening. Aerosolization of small glass particles in the airways could result in recurrent infections (due to obstruction of airways, and decreased clearance of airway secretions).

Acetylcysteine is indicated as adjuvant therapy for patients with abnormal, viscid, or inspissated mucous secretion. Acetylcysteine, administered orally, is indicated as an antidote to prevent or lessen hepatic injury which may occur following the ingestion of a potentially hepatotoxic quantity of acetaminophen.

The key component of this update is the extension of the recall to the patient level. This recall is limited to the one lot number listed above.

Hospitals, emergency rooms, clinics, physician offices and other healthcare facilities and providers should not use the product lot listed above for patient care and should immediately quarantine any product for return.

Patients that may have received product dispensed from this one lot should return the product to their pharmacist. Distributors/retailers that have not received a recall packet should contact GENCO Pharmaceutical Services, 6101 North 64th Street, Milwaukee, WI 53218.

For information regarding the recall process, call GENCO Pharmaceutical Services at 800-950-5479 and select menu option 1. For technical product information or to report a technical product complaint, call 800-962-8364 and select menu option 6.

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.

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

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


Read at BioSpace.com

   

ADD TO DEL.ICIO.US    ADD TO DIGG    ADD TO FURL    ADD TO STUMBLEUPON    ADD TO TECHNORATI FAVORITES
 

//-->