National Alert Network Issues Warning about Possible Mislabeled Overwrap of Premixed IV dexmedeTOMIDine Bags

The Institute for Safe Medication Practices (ISMP) has received a report of a Hikma premixed IV product with an overwrap labeled acetaminophen injection that may have contained a dexmedeTOMIDine for infusion instead. A National Alert Network (NAN) caution has been issued to raise awareness and recommend ways to prevent any potential errors.

ISMP has reached out to the US Food and Drug Administration (FDA) and Hikma, and the concern is being investigated. Impacted wholesalers have been notified to place the affected lot of Hikma’s acetaminophen 1,000 mg/100mL injection in quarantine, and a formal recall is being planned.

“While this is an unusual situation, ISMP recommends scanning the barcode directly on an infusion bag, not the overwrap, prior to administration,” says ISMP President Rita K. Jew, PharmD, MBA, BCPPS, FASHP. “Healthcare practitioners should be vigilant in checking the actual infusion bag for Hikma’s acetaminophen injection label, regardless of the lot.”

In addition, ISMP recommends that healthcare organizations:

• Check inventory, and if an infusion bag overwrap labeled as acetaminophen with lot number 24070381 is found, sequester the product until further instructions from the FDA/wholesaler.
• Educate staff to read infusion bag labels prior to barcode scanning and administration.
• Report any issues to ISMP, FDA, and the manufacturer.

For a copy of the NAN alert with more details on the error report received, visit: Manufacturer’s dexmedeTOMIDine premixed IV bags may be packaged within (ecri.org)

Contact

Renee Brehio, Medication Safety Analyst and Editor, rbrehio@ismp.org

About the Institute for Safe Medication Practices

The Institute for Safe Medication Practices (ISMP) is the nation’s first 501c (3) nonprofit organization devoted entirely to preventing medication errors. ISMP is known and respected for its medication safety information. For more than 30 years, it also has served as a vital force for progress. ISMP’s advocacy work alone has resulted in numerous necessary changes in clinical practice, public policy, and drug labeling and packaging. Among its many initiatives, ISMP runs the only national voluntary practitioner medication error reporting program, publishes newsletters with real-time error information read and trusted throughout the global healthcare community, and offers a wide range of unique educational programs, tools, and guidelines. In 2020, ISMP formally affiliated with ECRI to create one of the largest healthcare quality and safety entities in the world, and ECRI and the ISMP PSO is a federally certified patient safety organization by the U.S. Department of Health and Human Services. As an independent watchdog organization, ISMP receives no advertising revenue and depends entirely on charitable donations, educational grants, newsletter subscriptions, and volunteer efforts to pursue its life-saving work. Visit www.ismp.org and follow @ismp_org to learn more.