Sagent Pharmaceuticals (NASDAQ: SGNT) is recalling three lots of Vecuronium Bromide for Injection, 10mg (NDC number 25021-657-10). Vecuronium Bromide for Injection is a neuromuscular blocking agent used in addition to general anesthesia to facilitate insertion of endotracheal tubes, and to provide skeletal muscle relaxation during surgery or mechanical ventilation.
Sagent announced the voluntary nationwide recall because of the discovery of elevated levels of impurity detected during routine quality testing of stability samples at the 18-month interval. Sagent is not aware of any adverse patient events having actually resulted from the use of this product, but elevated impurity levels could cause prolonged neuromuscular blockage in critically ill patients suffering from renal failure. Sagent is continuing to investigate.
Lot numbers 11I30481A, 11I30721A and 11I32581A are affected. They were distributed to hospitals, wholesalers, and distributors between January and May 2012. The doses were manufactured by Turkey's Mustafa Nevzat Ilac Sanayii (MN Pharmaceuticals) and distributed by Sagent.
Sagent is notifying distributors and customers of the recall by fax, email, and certified mail.
