Department of Health

Fentanase, fentanyl citrate 250mcg/mL nasal spray products

Find out about the quality and safety concerns, what to do with the remaining stock and guidelines for alternative administration methods to maintain effective pain relief.

The Department of Health has been notified of concerns regarding the quality and safety of Fentanase nasal spray, which is not currently listed on the Australian Register of Therapeutic Goods (ARTG). As such, health services are advised to immediately cease using Fentanase.

A Victorian Response Group, involving HealthShare Victoria, Safer Care Victoria, and the Department of Health, is coordinating the response to ensure safety and continuity of clinical care. This response group is currently exploring alternative products. Should intranasal fentanyl be required for pain relief, fentanyl solution for intravenous use may be administered intranasally via a Mucosal Atomiser Device.

Situation

The Therapeutic Goods Administration (TGA) has advised that they are currently investigating the manufacture and use of Fentanase nasal spray (fentanyl citrate 250 mcg/mL, available as 25mcg/spray and 50mcg/spray nasal intranasal actuator devices). Fentanase is not listed on the ARTG and has not therefore been evaluated for quality, safety and efficacy in Australia.

Should intranasal fentanyl be required for pain relief, 100 microg/2 mL strength fentanyl solution for intravenous use may be administered intranasally using a Mucosal Atomiser Device (MAD300).

Recommendations

Immediately cease using Fentanase products and quarantine any remaining stock. Advise Safer Care Victoria via email CPLU@safercare.vic.gov.au of any remaining stock on hand (including quantities) as a matter of urgency.

Should intranasal fentanyl be required for pain relief, fentanyl solution for intravenous use may be administered intranasally via a Mucosal Atomiser Device (MAD300). Information on administration of intranasal fentanyl via the MAD is available from the Royal Children's Hospital, see Clinical Practice Guidelines : Intranasal fentanylExternal Link .

For general inquiries regarding this critical update, contact CPLU@safercare.vic.gov.au

Reviewed 16 May 2025

Health.vic

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