Recall -- Firm Press Release
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Bedford Laboratories Issues Guidance On 2011 Voluntary Recall Of Polymyxin B For Injection USP And Vecuronium Bromide For Injection Related To Glass Particles
FOR IMMEDIATE RELEASE - January 10, 2012 - 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
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.
- Online: www.fda.gov/medwatch/report.htm
- Regular Mail: Use postage-paid, pre-addressed Form FDA 3500 available at: www.fda.gov/medwatch/getforms.htm. Mail to address on the pre-addressed form.
- Fax: 1.800.FDA.0178
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.
Recalled Product Photos Are Also Available on FDA's Flickr Photostream.