A nurse removed a prefilled syringe of what they thought was morphine 2 mg/mL from an automated dispensing cabinet (ADC). The nurse identified that while the syringe packaging contained a tamper-evident seal labeled “Morphine 2 mg/mL,” the syringe was labeled DILAUDID (HYDROmorphone) 0.5 mg/0.5 mL (Figure 1). The nurse escalated this concern to pharmacy, and a total of 6 prefilled syringes with similar mismatched labels were found within the organization at that time. This was a good catch that did not reach the patient.
Figure 1. A nurse identified that the prefilled syringe of what was supposed to be morphine 2 mg/mL was labeled DILAUDID (HYDROmorphone) 0.5 mg/0.5 mL on the syringe barrel.
The impacted products are made by Fresenius Kabi. The HYDROmorphone prefilled syringe had an NDC of 76045-009-96, lot number 6402813, and expiration date 12/31/28. The syringe was removed from a carton labeled morphine 2 mg/mL, with an NDC of 76045-004-11, lot number 6402820, and expiration date 12/31/28 (Figure 2). The reporting organization tested the barcode on the HYDROmorphone syringe label and confirmed that it scans as HYDROmorphone.
Figure 2. A morphine 2 mg/mL carton contained syringes labeled as HYDROmorphone 0.5 mg/0.5 mL.
Over the years, ISMP has received many reports of confusion between the high-alert opioids, HYDROmorphone and morphine, some of which have been fatal. If barcode scanning is not available or bypassed, and a practitioner reads the morphine label on the top of the syringe packaging, they may assume the syringe contains 2 mg of morphine and unknowingly administer a syringe containing 0.5 mg of HYDROmorphone to a patient.
We have reached out to the US Food and Drug Administration (FDA) and Fresenius Kabi to notify them of this concern. Fresenius Kabi has confirmed that the contents of the syringes contain HYDROmorphone, and that no other lot numbers are impacted. They confirmed the syringe label scans as HYDROmorphone, and there is no barcode on the tamper-evident seal labeled “Morphine 2 mg/mL.” They told us that an investigation is in progress; they are in contact with FDA and will be in communication with customers. They did not have additional information on whether a formal recall is planned.
If your organization has purchased morphine 2 mg/mL prefilled syringes by Fresenius Kabi, immediately check your inventory in all locations. If impacted products are found, sequester them until further instructions are provided by the FDA/manufacturer. Educate staff to open the morphine cartons and read the prefilled syringe labels upon receipt in the pharmacy, prior to barcode scanning when refilling ADCs, and before barcode scanning prior to administration. Emphasize the need to be vigilant when checking the prefilled syringe labels for Fresenius Kabi’s HYDROmorphone and morphine injection, regardless of the lot. Report issues to ISMP, FDA, and the manufacturer.
