August 26, 2022

The World Health Organisation (WHO) has requested increased surveillance and diligence within the supply chains of countries and regions likely to be affected by falsified DIPRIVAN (propofol), identified in Venezuela (Bolivarian Republic of) in July 2022 and reported to WHO in August 2022.

According to WHO in a statement on Thursday, Genuine DIPRIVAN is manufactured by ASTRAZENECA for ASPEN and both companies have confirmed that the products referenced in the Alert are falsified on the basis that they deliberately/fraudulently misrepresent their identity and source.

DIPRIVAN is indicated for use as a short-acting intravenous general anaesthetic during diagnostic and surgical procedures, and for the sedation of ventilated patients.

WHO noted further that the stated Lot numbers are falsified and have never been issued for DIPRIVAN.

Printing and spelling errors have also been identified and the fill line is potentially inconsistent among the identified vials.

The safety, sterility, and quality of the falsified products referenced in this alert are unknown.

DIPRIVAN is administered intravenously and used to sedate patients. These falsified products may therefore pose a particular high risk to patients.

Advice to regulatory authorities and the public

All medical products must be approved and obtained from authorized/licensed suppliers. The products’ authenticity and physical condition should be carefully checked. Seek advice from a healthcare professional when in doubt.

If you are in possession of these falsified products, please do not use them.

If you have used these products, or you suffered an adverse reaction/event after use, you are advised to seek immediate medical advice from a qualified healthcare professional and report the incident to the National Regulatory Authority or National Pharmacovigilance Centre.

National regulatory/health authorities are advised to immediately notify WHO if these falsified products are discovered in their country.

WHO however advised that it is important for countries to detect and remove these falsified products from circulation to prevent harm to patients.