Medical Product Warning no. 4/2020

These medical device warnings apply to a number of confirmed counterfeit chloroquine products circulating in the African WHO region. Please note that this medical product alert no. 4/2020 to be updated as WHO receives new reports of counterfeit chloroquine.

Between 31 March and 2 April 2020 WHO global surveillance and monitoring system for non-standard and counterfeit (SF) medical products received nine reports of confirmed counterfeit chloroquine products from three countries. All reported products were identified at the patient level and all were confirmed forged.

This WHO medical device alert No. 4/2020 refers to nine different counterfeit chloroquine products with different views (see Table 1). It is important to note that wide alertness is required from all countries, regardless of where the product was originally identified.

Table 1: List of identified counterfeit chloroquine products, WHO alert no. 4/2020

All products listed in Table 1 are confirmed to be counterfeit on the grounds that they intentionally / fraudulently misrepresent their identity, composition or source. Indeed, it can be observed that:

• or: the products do not contain the correct amount of active pharmaceutical ingredient based on the results of preliminary or complete analytical analysis;
• and / or: the products were not manufactured by the manufacturer whose name is indicated on the product labels and the variable data (batch number and dates) of the above products do not correspond to the true production data;
• and / or: The manufacturer whose name appears on the product labels does not exist.

Chloroquine phosphate or sulfate is listed on the WHO Model List of Essential Medicines for the Treatment of Plasmodium Vivax (Malaria) Infection. Major clinical trials are underway to generate the powerful data needed to determine the efficacy and safety of chloroquine and hydroxychloroquinine in the treatment of COVID-19. These medicines are currently approved for malaria and certain autoimmune diseases and it is important that patients do not face deficiency caused by storage or use beyond the approved indications.
Both chloroquine and hydroxychloroquine can have serious side effects, especially at high doses or in combination with other medicines.

The SOLIDARITY trial, led by WHO, reviews possible treatment for COVID-19. Please see WHO medical device alert no. 3/2020 for general information about counterfeit medical products related to administration
of COVID-19.

For photographs of the products listed in Table 1, please refer to the section WHO Medical Device Alert Website, i
in support of this medical product alert no. 4/2020 (see pages 3-7).

WHO requires greater vigilance in the supply chains of countries likely to be affected by these counterfeit products. Increased alertness should include hospitals, clinics, health centers, wholesalers, distributors, pharmacies and all other suppliers of medical devices.

If you own the above products, do not use them. If you have used these counterfeit products, or if you have an adverse reaction / event using these products, we advise you to seek medical advice immediately from a qualified healthcare professional and to report the incident to the national regulatory authorities / National Pharmacovigilance Center,

All medical products must be sourced from licensed, authentic and trusted sources. Their authenticity and condition should be carefully checked. If in doubt, seek the advice of a healthcare professional.

National regulatory / health authorities are advised to notify WHO immediately if these counterfeit products are detected in their country. If you have any information on the production, distribution or supply of these products, please contact: [email protected].

WHO Global Surveillance and Surveillance System for Substandard and Counterfeit Medical Devices
For more information, visit: www.who.int/medicines/regulation/ssffc/en/

Photos of confirmed counterfeit tablets chlorine phosphate B.P 100mg