Monday, January 23, 2012

New Guidance on Recalls of Polymyxin B, Vecuronium

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The FDA yesterday issued an updated guidance on voluntary product recalls involving Bedford Laboratories injection drugs that were initially made on August 2, 2011, after the discovery of glass particles in some vials.
The drugs and lot numbers include:
  • polymyxin B for injection USP, 500,000 units/vial: NDC 55390-139-10, lot 1942980 (expiration date August 2013) and lot 1895027 (expiration date June 2013);
  • vecuronium bromide for injection, 10 mg/vial: NDC 55390-037-10, lot 1865067 (expiration date May 2012);
  • vecuronium bromide for injection, 20 mg/vial: NDC 55390-039-10, lot 1865069 (expiration date February 2012).
Polymyxin B is an antibiotic indicated in the treatment of acute infections caused by strains of Pseudomonas aeruginosa. Vecuronium bromide is a muscle relaxant used as an adjunct to general anesthesia to assist with endotracheal intubation or to enable relaxation of skeletal muscles during surgery or mechanical ventilation.
The FDA notes that there have been no reports of adverse events for the lots being recalled; however, hospitals, emergency departments, clinics, physician offices, and other healthcare facilities and providers are warned not to use the affected product lots and to immediately quarantine any product for return to the manufacturer.
Potential adverse events related to the injection of particulate matter in the bloodstream include vein irritation and phlebitis, pulmonary dysfunction and granulomas, local tissue infarction, occlusion of capillaries and arteries, anaphylactic shock, and death, according to the FDA.

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