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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 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
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