Falsified Medical Product Alert N°3/2021

CYTOTEC (misoprostol) 200 microgram tablets: falsified product alert

WHO issued this alert on two falsified batches of CYTOTEC reported to WHO in July 2021 at wholesale and patient level in four African countries. Laboratory analysis found batch B16519 contains no active ingredient. Misoprostol is on the WHO Model List of Essential Medicines and is used in obstetric care.¹

Health risk as statedWHO said the risk from falsified Cytotec is ineffective or delayed treatment, which could be life-threatening in some circumstances.

Issued: 10 August 2021
Issued by: World Health Organization
Name stated on packaging: Packaging bears the CYTOTEC brand. WHO did not name the company shown on the falsified packs.
Genuine manufacturer's statement: WHO said the genuine manufacturer of CYTOTEC confirmed the listed products are falsified because they failed laboratory analysis and/or show falsified variable data.
Countries where detected: Cameroon, Democratic Republic of the Congo, Ghana, Nigeria

Batches named in the alert

B16519 (does not correspond to genuine CYTOTEC), 14660 (falsified expiry date 12/2021)

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°3/2021: Falsified CYTOTEC (10 August 2021)