Product Recalled After Glass Particulates Found

Pharmaceutical Technology Editors

Sun Pharmaceutical Industries, Inc. is recalling lots of Vecuronium Bromide for Injection because of glass particulates.

FDA announced on January 8, 2019 that 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) because of glass particulates found in the product.

While the company states that it has not received any reports of adverse events, glass present in intravenous drugs may cause local irritation and/or blockage and clotting of blood vessels if administered. 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,” according to the company.

The recalled product, which is packaged in a glass vial, was distributed nationwide to wholesale customers and medical facilities. More information on lot numbers and expiration dates can be found at FDA.gov.

Source: FDA