DexmedeTOMIDine Premixed IV bags May Be Packaged Within an Overwrap Labeled as Acetaminophen

ECRI posted a National Alert Network (NAN) Alert regarding a Hikma product with an overwrap labeled acetaminophen injection 1,000 mg/100 mL (NDC 0143-9386-01, lot number 24070381, expiration date 09/2025). It may contain a dexmedeTOMIDine 400 mcg/100 mL infusion bag (lot number 24070461, expiration date 03/2026) with Canadian labeling, a different font, and follows ISMP Canada’s tall man lettering (i.e., dexmedeTOMidine) (www.ismp.org/ext/1394) which is different from the tall man lettering (i.e., dexmedeTOMIDine) on the ISMP List of Look-Alike Drug Names with Recommended Tall Man (Mixed Case) Letters (www.ismp.org/node/136).

The alert says, “An event was reported to ISMP [Institute for Safe Medication Practices]  where a nurse removed what she thought was an acetaminophen 1,000 mg/100 mL infusion bag from the automated dispensing cabinet (ADC), scanned the barcode on the overwrap, and administered the infusion to the patient. Approximately 15 minutes later, the patient experienced bradycardia and bradypnea. The nurse looked at the empty bag hanging on the intravenous (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. Fortunately, the patient recovered.”

Further, “We have reached out to the US Food and Drug Administration (FDA) and Hikma to notify them of this concern. Hikma told us they are conducting an immediate and ongoing investigation. They have notified the impacted wholesalers who have placed Hikma’s acetaminophen 1,000 mg/100 mL injection with the lot number 24070381 in quarantine. A formal recall is planned.”

The alert notes that if your organization has purchased this product, check inventory and if an infusion bag overwrap labeled as acetaminophen with lot number 24070381 is found, isolate the product until further instructions are provided by the FDA/wholesaler. The alert recommends scanning the barcode directly on an infusion bag (not the overwrap) prior to administration. Also, the alert suggest educating staff to read the infusion bag labels prior to barcode scanning and administration and urging vigilance when checking the infusion bag for  Hikma’s acetaminophen injection, regardless of lot.