Sunday, 25 August 2019

Sun Pharma recalls anesthesia injection from US market

10 January 2019 | News

Vecuronium Bromide for Injection is used as an adjunct to general anaesthesia, to facilitate endotracheal intubation and to provide skeletal muscle relaxation during surgery or mechanical ventilation and is packaged in a glass vial

Sun Pharmaceutical Industries, Inc. (SPII), a wholly owned subsidiary of 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. Sun Pharma said in a letter to the USFDA.

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 and is packaged in a glass vial.

This product was distributed nationwide to wholesale customers and medical facilities, the drug maker said. 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. To date, the company has not received any reports of adverse events related to this recall.

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