Sun Pharma recalls 140,000 vials contaminated with glass particles

By Ben Hargreaves contact

- Last updated on GMT

(Image: Getty/Esben_H)
(Image: Getty/Esben_H)

Related tags: Sun pharma, Vecuronium bromide, Fda

Sun Pharma has initiated a voluntary recall of vials containing vecuronium bromide, after they were found to be contaminated with glass.

The US Food and Drug Administration (FDA) made the announcement, after Sun Pharma notified its distributors and customers on January 3 of the issue.

The recall pertains to three lots of Vecuronium Bromide for Injection, 10 mg (lyophilized powder), and one lot of Vecuronium Bromide for Injection, 20 mg.

In total, the recall involves 139,180 vials that were distributed in the US and may contain glass particulate.

At the time of reporting, Sun Pharma had not received any reports of adverse events related to the recall.

The FDA warned that the intravenous administration of the drug containing glass particulate could result in local irritation or swelling. More serious events could lead to the blockage or clotting of blood vessels, which could be life threatening.

Vercuronium bromide is used as an adjunct to general anaesthesia to facilitate endotracheal intubation and to provide skeletal muscle relaxation during surgery or mechanical ventilation.

In August 2018​, Sun Pharma experienced similar issues with vials of testosterone cypionate, which were found to contain organic and inorganic compounds. This discovery led to a voluntary recall being issued for the 5,215 units potentially contaminated.

Sun Pharma was not immediately available for comment.

Related topics: Regulatory & Safety, Regulations, QA/QC

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