Sagent Pharma expands voluntary withdrawal of vecuronium inj vials

US drugmaker Sagent Pharmaceuticals (Nasdaq: SGNT) said today (June 13) that it is expanding its voluntary nationwide recall of vecuronium bromide for injection 10mg (NDC number 25021-657-10) manufactured by Turkey-based Mustafa Nevzat Ilac Sanayii (MN Pharmaceuticals) and distributed by Sagent. This recall is being conducted with the knowledge of the US Food and Drug Administration.

Sagent initiated a voluntary recall of the drug to the user level for three lots on June 7, 2013 due to the discovery of an elevated impurity result detected during routine quality testing of stability samples at the 18-month interval. 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.