Express Pharma

Sun Pharma recalls about 14k cartons of anaesthesia injection from US market

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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 has said its US subsidiary has started voluntarily recalling 13,918 cartons of Vecuronium Bromide Injection of 10 mg and 20 mg strengths from US market at hospital level, following the identification of ‘particulate matter identified as glass’ in the product.

The Vecuronium Bromide for injection has been found to contain particulate matter identified as glass,” Sun Pharma said in a letter to the US Food and Drug Administration on January 8.

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.

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, the letter said.

 

 

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