MEDICAL PRODUCT ALERT 1 - UNREGISTERED MEDICAL PRODUCTS WITH CHINESE LABELS IN SUPERMARKETS IN GHANA

Alert Summary

The Food and Drugs Authority (FDA), Ghana reports of unregistered Chinese-labelled medicines sold in identified supermarkets in the Greater Accra Region of Ghana. The products were detected during Market Surveillance (MS) activities in some Chinese supermarkets in Tema . Classes of medicines found in the supermarkets are Analgesics, Antibiotics, Antihelmintics and Antipsychotics. The medicines are classified as Over-the-Counter Medicines (OTCs) and Prescription- Only Medicines (POMs). The FDA has taken the necessary regulatory sanctions against the facilities where the medical products were found including seizure of the medicines. How to identify this unregistered products

To identify these product check for the following:

• The products have inscriptions written in Chinese language only
• Some of the products have no Patient Information Leaflet (PIL) inserted in the product packages
• Products with Patient Information Leaflet (PIL) inserted in the product packages do not have information in English
• The products cannot be found on FDA website or register for list of registered products since they have not been approved by the FDA . Please refer to the attachment of this Alert for details of the unregistered products.

Risks

• The unregistered medical products have not been evaluated by the FDA, therefore their safety, quality and efficacy cannot be guaranteed
• The medical products are being dispensed from unlicensed facilities hence the storage conditions cannot be guaranteed
• The products pose significant risk to users since information is not in the official language (English) and critical information such as indications, dosing, expected adverse effects and management, contra-indications cannot be interpreted.

Advice to healthcare professionals, regulatory authorities and the public

If you are in possession any of the products, the FDA recommends that you do not use them and return them to the nearest FDA office or health facility. If you, or someone you know, has, or may have used these products, or suffered an adverse event or unexpected side-effect after use, seek immediate medical advice from a healthcare professional or contact a the FDA in any of our offices or through our social media handles. Note that all medical products must be obtained from authorized/licensed suppliers and not supermarkets. If you have any information about the supply of these Chinese labelled medical products, please contact the FDA.