Sun Pharma recalls around 14,000 cartons of anaesthesia injection from US market

Hyderabad: 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 the 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. [caption id=“attachment_2159087” align=“alignleft” width=“380”] Representational image. Reuters[/caption] 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 8 January. 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 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.     To keep watching India’s No. 1 English Business News Channel – CNBC-TV18, call your Cable or DTH Operator and ask for the Colors Family Pack (inclusive of 24 channels), available for Rs. 35/- per month, or subscribe to the channel for Rs. 4/- per day. To keep watching the Leader in Global Market & Business News – CNBC-TV18 Prime HD, call your Cable or DTH Operator and ask for the Colors Family HD Pack (inclusive of 25 channels), available for Rs. 50/- per month, or subscribe to the channel for Rs. 1/- per day.