Published on January 05, 2021

Costa Rica | Sanitary alert for counterfeit medicine detected in Brazil and Turkey

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HEALTH ALERT FOR COUNTERFEIT MEDICINES DETECTED IN BRAZIL AND TURKEY: (Ministry of Health 8 December 20)

The Directorate of Regulation of Health Products received the Medical Products Alert No. 7/2020 issued today by the World Health Organization about the antiviral drug HARVONI, which is indicated for the treatment of chronic Hepatitis C. As it is a product that is commercialized in Costa Rica, the present communication is issued.


Description of the counterfeit product: Harvoni90 mg/400 mg (Ledipasvir/Sofosbuvir) Lot 22VMYVA12 with expiration date 12 2022 in German language on the label. Identified in Brazil in May 2020 and in Turkey in November 2020 The WHO has received recent information indicating that these products are still in circulation. Previous records of other counterfeit HARVONI batches are in the WHO Global Surveillance and Monitoring System database. See photographs of the batch identified in Turkey.


In Costa Rica there is a valid health registration for the drug Harvoni90 mg/400mg coated tablets manufactured by Patheon Inc. of Canada with holder Gilead Sciences Inc: M-CA-16-00332.


It should be remembered that Article 107 of the General Health Law No. 5395 states "It is prohibited to import, manufacture, trade, distribute or supply in any way, manipulate, use, consume or possess for trade, deteriorated, adulterated or counterfeit medicines".

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