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Sun Pharmaceutical Industries, Inc. Issues Voluntary Recall of Vecuronium Bromide for Injection

Particulate Matter Identified as Glass Discovered in Agent

Sun Pharmaceutical Industries has issued a voluntary recall for three lots of Vecuronium Bromide for Injection, 10 mg (lyophilized powder) and 20 mg (lyophilized powder). The recall was issued nationwide to the hospital level after particulate glass was found in the drug.  

Vecuronium Bromide for Injection is used as an adjunct to general anesthesia, to facilitate endotracheal intubation, and to provide skeletal muscle relaxation during surgery or mechanical ventilation. The drug is packaged in glass vials, with ten vials in each carton.

Glass particulate may cause local irritation or swelling if it is present in an intravenous drug. More serious potential outcomes include blockage and clotting in blood vessels, which may be life-threatening. The manufacturer has not received any reports of adverse events relating to this recall.

Vecuronium Bromide for Injection was distributed nationwide to wholesale customers and medical facilities. Distributors and facilities that have the product that is being recalled should cease using it and return it to the place of purchase or as directed in the recall notification.

Sources: FDA.gov and Drugs.com, January 8, 2019.

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