Recall of Vecuronium Bromide for Injection

Alert from U.S. Food & Drug Administration

 

08 January 2019

 

Sun Pharmaceutical Industries, Inc. Issues Voluntary Nationwide Recall of Vecuronium Bromide for Injection Due to the Presence of Particulate Matter Identified as Glass

 

  • Sun Pharmaceutical Industries, Ltd. is voluntarily recalling three lots of Vecuronium Bromide for Injection, 10 mg (lyophilized powder), and one lot of Vecuronium Bromide for Injection, 20 mg (lyophilized powder) to the hospital level. The Vecuronium Bromide for Injection has been found to contain particulate matter identified as glass
  • The administration of a glass particulate, if present in an intravenous drug, may result in local irritation or swelling in response to the foreign material. More serious potential outcomes would include blockage and clotting in blood vessels, which may be life-threatening

 

What is Vecuronium Bromide?

  • Vecuronium Bromide for Injection is used as an adjunct to general anesthesia, to facilitate endotracheal intubation and to provide skeletal muscle relaxation during surgery or mechanical ventilation

 

Please see the FDA website for the Vecuronium Bromide lot numbers effected by the recall,

https://www.fda.gov/Safety/Recalls/ucm629328.htm?utm_campaign=FDA%20MedWatch%20Recall%20Notice%20-%20Vecuronium%20Bromide%20for%20Injection&utm_medium=email&utm_source=Eloqua