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Sun Pharmaceutical said its United States (US) subsidiary has started voluntarily recalling 13,918 cartons of Vecuronium Bromide Injection of 10 milligrams (mg) and 20 mg strengths from US market at hospital level, following the identification of “particulate matter identified as glass” in the product.
“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 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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