Sun Pharmaceutical Industries, Inc. (SPI) is voluntarily recalling 3 lots of 10 mg vecuronium bromide for injection and 1 lot of 20 mg vecuronium bromide for injection to the hospital level.
Sun Pharmaceutical Industries, Inc. (SPI) is voluntarily recalling 3 lots of 10 mg vecuronium bromide for injection (lyophilized powder) and 1 lot of 20 mg vecuronium bromide for injection (lyophilized powder) to the hospital level. These products have been found to contain particulate matter identified as glass.
The administration of a 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 include blockage and clotting in blood vessels, which may be life-threatening. To date, SPI has not received any reports of adverse events related to this recall.
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. This drug should be administered by or under the supervision of experienced clinicians and must be reconstituted prior to use, according to the FDA. The recalled vecuronium bromide for injection is packaged in a glass vial, with 10 vials per carton.
The recalled product was distributed nationwide to wholesale customers and medical facilities. A full list of the affected lots can be viewed on the FDA’s website.
Consumers should contact their physician or healthcare provider if they have experienced any problems that may be related to taking or using this drug product. Consumers with questions regarding this recall can contact SPII by calling 1-800-406-7984 or e-mailing drug.safetyUSA@sunpharma.com.
Sun Pharmaceutical Industries, Inc. Issues Voluntary Nationwide Recall of Vecuronium Bromide for Injection Due to the Presence of Particulate Matter Identified as Glass [announcement]. Silver Spring, MD; January 8, 2019: FDA website. https://www.fda.gov/Safety/Recalls/ucm629328.htm?utm_campaign=FDA%20MedWatch%20Recall%20Notice%20-%20Vecuronium%20Bromide%20for%20Injection&utm_medium=email&utm_source=Eloqua&rel=0" &rel=0" &rel=0" . Accessed January 8, 2019.