Counterfeit Alert

Falsified Medical Product Alert N°6/2020

Fluzone Quadrivalent Influenza Vaccine: falsified product alert

WHO issued this alert on three falsified batches of Fluzone Quadrivalent influenza vaccine identified at patient level in Mexico and reported to WHO on 16 October 2020. WHO said genuine Fluzone Quadrivalent had not yet been legitimately distributed in Mexico.1,2

Health risk as statedNo explicit health risk statement on the alert page. WHO said early identification of falsified influenza vaccines is crucial during the COVID-19 pandemic.
Issued
30 October 2020
Issued by
World Health Organization
Name stated on packaging
Packaging bears the Fluzone brand of Sanofi Pasteur with batch numbers and expiry dates that do not correspond to genuine records.
Genuine manufacturer's statement
WHO said Sanofi Pasteur confirmed it did not produce or distribute the products.
Countries where detected
Mexico

Batches named in the alert

EUH2174AC (stated expiry ENE 22), EUH071AB (stated expiry ENE 22), E0H071AB (stated expiry ENE 22)

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

  1. World Health Organization, Medical Product Alert N°6/2020: Falsified Fluzone Quadrivalent Influenza Vaccine (30 October 2020)
  2. World Health Organization, Medical Product Alert N°6/2020: annex (PDF) (30 October 2020)