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Three Lots of Vecuronium Bromide for Injection Recalled Due to Elevated Impurity Levels


Sagent Pharmaceuticals, Inc. of Schaumburg, Illinois, recalled three lots of Vecuronium Bromide for Injection 10mg (NDC number 25021-657-10) manufactured by Mustafa Nevzat Ilac Sanayii A.S. (MN Pharmaceuticals) and distributed by Sagent. This recall was initiated due to the discovery of an elevated impurity result detected during routine quality testing of stability samples at the 18-month interval. The elevated impurity result has the potential to result in prolonged neuromuscular blockade for critically ill patients with renal failure.

 

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 distributors and customers and is arranging for the return of all recalled product. Customers have been 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.

 

See the Recall

 

See also Medical Law Perspectives, August 2012 Report: Anesthesiology Errors: Complications, Malpractice, and Catastrophe.

 

See also Medical Law Perspectives, May 2013 Report: Drugs, Dosage, and Damage: Physician Liability for Prescribing or Administering Medication.

 

 

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