Falsified Medical Product Alert N°3/2023
DEFITELIO (defibrotide sodium): falsified product alert
WHO issued this alert on falsified DEFITELIO, a medicine for severe hepatic veno-occlusive disease after stem cell transplantation. The national regulator of the United Arab Emirates publicly reported the falsified batch in November 2022 and it was identified in Kyrgyzstan in March 2023. Analysis of a sample found none of the stated active ingredient. WHO said it knew of no adverse event reports.1
- Issued
- 11 April 2023
- Issued by
- World Health Organization
- Name stated on packaging
- Packs state batch 19G19A, which WHO reported is not a genuine DEFITELIO batch number. Packaging was found in UK and Ireland and US versions.
- Genuine manufacturer's statement
- WHO said the genuine manufacturer confirmed the products are falsified, that 19G19A and M06B466E are not genuine batch numbers and that the expiry dates are falsified.
- Countries where detected
- United Arab Emirates, Kyrgyzstan
Batches named in the alert
19G19A (stated on packs), M06B466E (on a vial inside a falsified US pack labelled 19G19A)
Advice as stated
Do not use the listed products. Obtain medicines only from authorised or licensed suppliers and check their authenticity and condition. Report adverse events or suspected falsification 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°3/2023: Falsified DEFITELIO (defibrotide sodium) (11 April 2023)