MUMBAI: Sun Pharma’s US subsidiary 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, says a USFDA notice. 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, it adds. The company has not received yet any reports of adverse events, it says.
Vecuronium Bromide for Injection is used as an adjunct to general anesthesia, and is packaged in a glass vial; ten vials per carton.