Falsified Medical Product Alert N°7/2023
DEFITELIO (defibrotide sodium): falsified product alert
WHO issued this alert on one falsified batch of DEFITELIO detected in India in April 2023 and Türkiye in July 2023. The product was supplied outside regulated and authorised channels and DEFITELIO has no marketing authorisation in either country. WHO said it was not aware of any reports of adverse events.1,2
- Issued
- 4 September 2023
- Issued by
- World Health Organization
- Name stated on packaging
- Falsified packs in UK and Ireland packaging carry batch number 20G20A. WHO said genuine DEFITELIO lot 20G20A was packaged in German and Austrian packaging.
- Genuine manufacturer's statement
- WHO said the genuine manufacturer of DEFITELIO confirmed that the product referenced in the alert is falsified. The serial number and stated expiry date do not match genuine records.
- Countries where detected
- India, Türkiye
Batches named in the alert
20G20A (printed on falsified UK and Ireland packs, stated expiry 08/2024)
Advice as stated
Do not use the listed products. Anyone who used them or had an adverse reaction should seek medical advice and report it to the national regulatory authority or pharmacovigilance centre.
Names printed on falsified products are not evidence that the named company made them. Where WHO or a regulator reports the genuine manufacturer's statement, it is shown.
Sources
- World Health Organization, Medical Product Alert N°7/2023: Falsified DEFITELIO (defibrotide) (4 September 2023)
- World Health Organization, Medical Product Alert N°7/2023: annex (PDF) (4 September 2023)