BETHESDA, MD 14 June 2013—The recall of 10-mg vecuronium bromide for injection distributed by Illinois-based Sagent Pharmaceuticals Inc. now applies to all lots of the 10-mg product manufactured from July 2011 to May 2012, the company announced Thursday.
Sagent said it expanded the recall, originally covering three lots, because of the results of additional analyses.
Routine stability tests of reserve samples from those three lots had shown an "elevated impurity result." The company had said the presence of an elevated amount of the unnamed impurity could result in longer-than-expected neuromuscular blockade in critically ill patients with renal failure.
Vials in the 54 lots were distributed to hospitals, wholesalers, and distributors from August 2011 through May 2013, Sagent said.
The company began distributing vecuronium in August 2011.
Sagent said its distributor, DDN, is notifying customers about the recall and arranging for return of the vials.
Questions about the return of unused vials should be directed to Sagent's customer service call center at 866-625-1618, 8 a.m. to 7 p.m. CST Monday through Friday.
Sagent's vecuronium bromide products were manufactured by a company in Turkey. That company, Mustafa Nevzat Ilac Sanayii A.S., was acquired by Amgen in June 2012.