Lot 24070381 is being pulled from the market because the bags might contain dexmedetomidine 400 micrograms per 100 milliliters, but the overwraps are labeled as acetaminophen injection 10 milligrams per milliliter.
If the incorrect medication is administered, patients might experience “varying degrees of sedation, bradypnea, bradycardia, hypertension, and hypotension or more serious and potentially life-threatening outcomes,” the FDA said.
The Institute for Safe Medication Practices raised the issue July 11. A nurse told the ISMP that she removed what was thought to be an acetaminophen injection bag from an automated dispensing cabinet, scanned the barcode on the overwrap and administered the drug. About 15 minutes later, the patient experienced bradycardia and bradypnea.
The empty bag on the IV pole was labeled as dexmedeTOMidine hydrochloride injection. The nurse contacted the physician, and the patient received supplemental oxygen and recovered.
To date, Hikma has received one adverse event report.
At the Becker's 11th Annual IT + Revenue Cycle Conference: The Future of AI & Digital Health, taking place September 14–17 in Chicago, healthcare executives and digital leaders from across the country will come together to explore how AI, interoperability, cybersecurity, and revenue cycle innovation are transforming care delivery, strengthening financial performance, and driving the next era of digital health. Apply for complimentary registration now.