Schaumburg-based Sagent Pharmaceuticals has initiated a voluntary nationwide recall of three lots of Vecuronium Bromide for Injection 10mg, manufactured by Mustafa Nevzat Ilac Sanayii A.S. and distributed by Sagent.
Sagent said it initiated the recall after the discovery of an elevated impurity result detected during routine quality testing. The elevated impurity result has the potential to result in prolonged neuromuscular blockade for critically ill patients with renal failure, the company said in a release.
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The company said it is not aware of any adverse patient events resulting from the use of this product and is continuing its diligent investigation of the situation.
The lot numbers being recalled are: 11I30481A, 11I30721A and 11I32581A, which were distributed to hospitals, wholesalers and distributors nationwide from January 2012 through May 2012. 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.
Sagent's Distributor DDN is notifying Sagent's distributors and customers by fax, email and certified mail and is arranging for return of all recalled product. Customers are instructed to examine their inventory immediately and to quarantine, discontinue distribution of and return all recalled lots of the product.
Customers who may have further distributed this product have been requested to identify their customers and notify them at once of this product recall. The necessary form by which to document this information as well as other information regarding this recall is available at www.Sagentpharma.com.
This recall is being conducted with the knowledge of the U.S. Food and Drug Administration.
Any questions about returning unused product should be directed to the customer call center at (866) 625-1618 Monday through Friday. 8 a.m.-7 p.m. Healthcare workers who have medical questions about Vecuronium bromide for Injection may contact Sagent Medical Affairs (866-625-1618, Option 3) Monday-Friday, 8 a.m.-7 p.m.