Medical Product Warning no. 4/2019 (English version)

Counterfeit oral cholera vaccines circulating in Bangladesh

This medical device notice is for the circulation of confirmed counterfeit DUKORAL in the WHO region of Southeast Asia, True ducoral is a WHO vaccine for oral cholera.

The manufacturer of Valneva recently informed the WHO that 8000 counterfeit packs of oral Dukoral cholera vaccine have been distributed in Bangladesh. The Bangladesh Land Office and health authorities have quarantined the counterfeit vaccines discovered to date.

The packaging of this counterfeit Dukoral displays text in English and French.

Samples are sent for laboratory analysis to determine their content and better risk assessment for public health. This medical product alert no. 4/2019 will subsequently be updated and published on the WHO website after the results of the laboratory are obtained. No serious adverse reactions attributed to these counterfeit vaccines have been reported at this stage of WHO.

The manufacturer of the original Dukoral is Valneva Sweden AB, formerly called Crucell Sweden AB.

The above product claims to be manufactured by Valneva Canada Inc. However, the manufacturer Valneva Sweden AB stated that:

• the batch number shown does not match the original production data of either Valneva Canada Inc, or Crucell; and
• the combination of Valneva Canada Inc. and Crucell manufacturers should not exist on any packaging in any market.

The following page shows photos of the counterfeit Dukoral theme of this alert and provides advice for healthcare professionals and patients.

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

If you own the above products, do not use them. If you have taken this counterfeit product or suffered an adverse event or unexpected lack of efficacy, seek the advice of a qualified healthcare professional immediately and ensure that they report the incident to your local Ministry of Health / National Medicines Regulatory Authority / National Pharmacovigilance Center.

All medical products must be obtained from credible and reliable sources. Their authenticity and condition should be carefully checked. If in doubt, seek the advice of a healthcare professional.

National health authorities ask you to notify WHO immediately if fake 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 products

For more information, visit: http://www.who.int/medicines/regulation/ssffc/en/

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