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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

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.

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