Sun Pharma issues recall of IV muscle relaxant after glass fragments found

Sun Pharma sign
The recall includes three lots of 10 milligrams of lyophilized powder and one lot of 20 milligrams of lyophilized powder, both of which must be reconstituted before being administered. (Sun Pharma)

India’s Sun Pharmaceuticals has issued a voluntary recall of four lots of the muscle relaxant vecuronium bromide for injection after particulate matter identified as glass was found in the product.

The recall includes three lots of 10 milligrams of lyophilized powder and one lot of 20 milligrams of lyophilized powder, both of which must be reconstituted before being administered.

Sun said in the recall posted on the FDA’s website that the product was distributed nationwide in the U.S. to wholesale customers and medical facilities. It began notification of the recall earlier this month.

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To date, the company said, no adverse events related to the recall have been reported.

Vecuronium bromide, which is sold under the brand name Norcuron as well as other names, is used during general anesthesia to aid in intubation by relaxing skeletal muscles. 

Sun is currently under investigation by the Securities and Exchange Board of India for alleged insider trading claims related to the 2014 acquisition of its former rival Ranbaxy from Japan’s Daiichi Sankyo. According to reports, a whistleblower accused Sun of manipulating stock prices of its acquisition targets directly or indirectly.