ISMP Issues Warning Over Mislabeled Hikma Acetaminophen IV Bags

According to a recent alert issued by the Institute for Safe Medication Practices (ISMP), certain acetaminophen infusion bags made by Hikma may actually contain a sedative, instead of the pain medication, which could lead to unintentional sedation, cardiovascular effects and failure to provide pain relief.

The prominent drug safety organization issued a Hikma Acetaminophen IV Bag warning on July 11, indicating that bags labeled as acetaminophen injection 1,000 mg/100 mL may contain dexmedetomidine 400 mcg/100 mL.

While acetaminophen is typically used for intravenous pain management and fever reduction, dexmedetomidine is a sedative used in intensive care units or during surgeries to provide sedation without respiratory depression and possesses analgesic properties.

The ISMP is a nonprofit organization that enhances medication safety through research and education, while also collaborating with regulatory agencies and the pharmaceutical industry to develop and implement robust safety standards and protocols.

According to the alert, a formal Hikma acetaminophen IV bag recall is planned by the manufacture and U.S. Food and Drug Administration (FDA), but the safety group is urging medical providers to check their inventory, and if an infusion bag overwrap labeled as acetaminophen with lot number 24070381 is found, it should be sequestered until further instructions are provided by the wholesaler or FDA.

The ISMP issued the warning after receiving a report of a nurse mistakenly taking what she thought was an acetaminophen 1,000 mg/100 mL infusion bag from the automated dispensing cabinet (ADC). She scanned the barcode on the overwrap and administered the infusion to the patient.

About 15 minutes later, the patient experienced a slow heart rate and breathing, the ISMP reports. The nurse then noticed the empty bag on the IV pole was labeled “dexmedetomidine hydrochloride injection, 400 mcg/100 mL.” She notified the doctor and provided the patient with supplemental oxygen. Fortunately, the patient recovered.

As of now, the ISMP has notified the Food and Drug Administration (FDA) and Hikma, who stated they will be conducting an immediate and ongoing investigation. The affected wholesalers have also been notified and have quarantined Hikma’s acetaminophen 1,000 mg/100 mL injection IV bags with lot number 24070381. A formal recall is forthcoming, the ISMP indicates.

Although this situation is rare, the ISMP is reminding medical providers that it is best practice to scan the barcode directly on the infusion bag (not the overwrap) before administration. Any reports of problems with the acetaminophen IV bags can be submitted to the ISMP, FDA, and the manufacturer.