14 May 2025 Medical product alert Geneva Reading time: 2 min (474 words)
This WHO Medical Product Alert refers to three batches of falsified IMFINZI (durvalumab) injection 500mg/10ml. The falsified products have been detected in the Islamic Republic of Iran and Türkiye. These falsified products were reported to WHO in March 2025.
WHO previously issued Medical Product Alert N°5/2024 regarding another falsified batch of IMFINZI that was detected in Armenia, Lebanon, and Türkiye.
IMFINZI is a sterile concentrate for infusion. It contains the active pharmaceutical ingredient durvalumab, which is a monoclonal antibody. As monotherapy, it is indicated for the treatment of Non-Small Cell Lung Cancer (NSCLC) in adults.
These products are falsified as they deliberately misrepresent their identity, composition, and source. The genuine manufacturer, AstraZeneca, has identified multiple visual discrepancies in the falsified products. AstraZeneca has confirmed that the products mentioned in this alert are indeed falsified. Check for the following and see the Annex below for more details:
These falsified products should be considered unsafe, and their use may be life-threatening in some circumstances. The use of these falsified IMFINZI injections may lead to ineffective or delayed treatment. It is important to detect and remove any falsified IMFINZI (durvalumab) injections from circulation to prevent harm to patients.
Health-care professionals should report any incident of adverse effects, lack of expected effects or suspected falsification to the National Regulatory Authorities or National Pharmacovigilance Centre.
WHO advises increased surveillance and diligence within the supply chains of countries and regions likely to be affected by these falsified products. Increased surveillance of the informal/unregulated market is also advised. National regulatory authorities/health authorities/law enforcement are advised to immediately notify WHO if the falsified product is detected in their country. If you are in possession of any of these products, WHO recommends that you do not use them. If you, or someone you know, has, or may have used these products, or suffered an adverse event or unexpected side-effect after use, seek immediate medical advice from a health-care professional or contact a poisons control centre.
All medical products must be obtained from authorized/licensed suppliers. If you have any information about the manufacture or supply of these falsified products, please contact WHO via rapidalert@who.int.
Annex: Products subject to WHO Medical Product Alert N°3 /2025