NAN Alert: Manufacturer's Product Labeled as Acetaminophen May Contain DexmedeTOMIDine

Hikma's dexmedeTOMIDine premixed intravenous (IV) bags may be packaged within an overwrap labeled as acetaminophen, according to a new warning from the National Alert Network (NAN).

The alert was issued after the Institute for Safe Medication Practices (ISMP) learned that a nurse had removed what was labeled as an acetaminophen 1,000 mg/ 100 mL infusion bag from an automated dispensing cabinet, scanned the barcode on the overwrap, and administered the medication to a patient.

Approximately 15 minutes later, the patient experienced bradycardia and bradypnea. The nurse looked at the empty bag hanging on the IV pole and discovered that it was labeled “dexmedeTOMidine hydrochloride injection 400 mcg/100 mL.” The nurse notified the prescriber and provided supplemental oxygen to the patient. The patient recovered.

The affected Hikma product has an overwrap labeled acetaminophen injection 1,000 mg/100 mL (NDC 0143-9386-01, lot number 24070381, expiration date 09/2025). The dexmedeTOMIDine 400 mcg/100 mL infusion bag (lot number 24070461, expiration date 03/2026) features Canadian labeling, a different font, and follows ISMP Canada’s tall man lettering (dexmedeTOMidine). That is different from the tall man lettering (e.g., dexmedeTOMIDine) on the ISMP List of Look-Alike Drug Names with Recommended Tall Man (Mixed Case) Letters.

ISMP has notified the Food and Drug Administration (FDA) and Hikma of the report. Hikma told ISMP that it has launched an investigation and alerted wholesalers, who placed Hikma’s acetaminophen 1,000 mg/100 mL injection with the lot number 24070381 in quarantine. A formal recall is planned.

Organizations that have purchased this Hikma drug should check their inventories and sequester any product with an infusion bag overwrap labeled as acetaminophen and lot number 24070381 until further instructions are provided by the FDA or wholesalers.

While this is an unusual situation, the best practice is to scan the barcode directly on an infusion bag —not the overwrap — prior to administration. Organizations should educate their staff to read the infusion bag labels prior to barcode scanning and administration and to be vigilant when checking the actual infusion bag for Hikma’s acetaminophen injection, regardless of the lot.

Report issues to ISMP, FDA, and the manufacturer.

NAN is a coalition of members from the National Coordinating Council for Medication Error Reporting and Prevention (NCC MERP). The network, in cooperation with ISMP and ASHP, distributes NAN alerts to warn healthcare providers about the risk of medication errors that have caused or may cause serious harm or death, or to warn them about new findings that could cause harm or are being reported with unusual frequency. NCC MERP, ISMP, and ASHP encourage the sharing and reporting of medication errors both nationally and locally, so that lessons learned can be used to increase the safety of the medication-use system.