Schaumburg-based Sagent Pharmaceuticals has expanded its voluntary nationwide recall of Vecuronium Bromide for Injection 10mg, manufactured by Mustafa Nevzat Ilac Sanayii A.S. and distributed by Sagent.
Sagent initiated a voluntary recall of Vecuronium Bromide for Injection to the user level for three lots on June 7 due to the discovery of an elevated impurity result detected during routine quality testing of stability samples at the 18-month interval.
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Based on the results of additional analyses conducted since the initial recall, Sagent expanded its recall of Vecuronium Bromide for Injection, 10mg to the user level to include all lots manufactured between July 2011 and May 2012.
The elevated impurity result has the potential to result in prolonged neuromuscular blockade for critically ill patients with renal failure. Sagent is not aware of any adverse patient events resulting from the use of this product to date.
Vecuronium bromide is used as an adjunct to general anesthesia, to facilitate endotracheal intubation, and to provide skeletal muscle relaxation during surgery or mechanical ventilation. The subject lots were distributed to hospitals, wholesalers and distributors nationwide from August 2011 through May 2013. Vecuronium Bromide for Injection is a neuromuscular blocking agent indicated as an adjunct to general anesthesia, to facilitate endotracheal intubation and to provide skeletal muscle relaxation during surgery or mechanical ventilation and is supplied in a glass vial.
More information and viewed at http://www.sagentpharma.com/recallmenu/vecuronium-bromide-recall-information.html.
The recall is being conducted with the knowledge of the U.S. Food and Drug Administration.