Falsified Medical Product Alert N°9/2021
Soliris (eculizumab): falsified product alert
WHO issued this alert on falsified Soliris, a medicine for rare blood and neurological disorders, reported to WHO between November and December 2021. WHO said the products were reported at patient level and in regulated supply chains.1,2
- Issued
- 22 December 2021
- Issued by
- World Health Organization
- Name stated on packaging
- Table 1 gives ALEXION as the stated manufacturer of SOLIRIS 300mg. WHO said the genuine manufacturer confirmed the products are falsified.
- Genuine manufacturer's statement
- WHO said the genuine manufacturer of Soliris confirmed that the products listed in the alert are falsified.
- Countries where detected
- Argentina, Estonia, India, Uruguay
Batches named in the alert
1012401 (stated expiry SEP 22, Spanish packaging), 1013715 (stated expiry FEB 22, Spanish packaging), 1001600 (stated expiry 03/2023, English packaging), 1001701 (stated expiry 03/2023, Turkish packaging)
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°9/2021: Falsified Soliris (22 December 2021)
- World Health Organization, Medical Product Alert N°9/2021: annex (PDF) (22 December 2021)