Falsified Medical Product Alert N°5/2020
Defibrotide 200mg vials of 2.5ml (Defitelio): falsified product alert
WHO issued this alert after falsified defibrotide was found at patient level in Australia in March 2020 and reported from Saudi Arabia in April 2020, with an update on 1 July 2020 adding Argentina and Malaysia. Analyses found none of the expected active ingredient and contamination with Cladosporium sp. and Aspergillus niger. Both batches were in Latvia's regulated supply chain as early as January 2020.1
- Issued
- 7 May 2020
- Issued by
- World Health Organization
- Name stated on packaging
- Packaging bears the Defitelio brand and batch numbers 0286 and 0126, which are genuine batch numbers of GENTIUM S.R.L.
- Genuine manufacturer's statement
- WHO said GENTIUM S.R.L. confirmed that it did not manufacture the products.
- Countries where detected
- Australia, Saudi Arabia, Latvia, Argentina, Malaysia
Batches named in the alert
0286 (expiry 09/2021), 0126 (expiry 08/2021)
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°5/2020: Falsified and contaminated Defibrotide (7 May 2020)