TANZANIA MEDICINES AND MEDICAL DEVICES AUTHORITY

ISO 9001: 2015 CERTIFIED

PUBLIC NOTICE

11^th September, 2019

FALSIFIED “AUGMENTIN 625MG” TABLETS ON THE TANZANIAN MARKET

1. Tanzania Medicines and Medical Devices Authority (TMDA) is an Executive Agency under the Ministry of Health, Community Development, Gender, Elderly and Children, which is responsible for regulating quality, safety and effectiveness of medicines, medical devices and diagnostics.
2. Through the surveillance system, TMDA has encountered a falsified medicine in the market, named as “Augmentin 625mg” in form of tablets, which is purported to be manufactured by a company namely SmithKline Beecham Limited, Worthing, UK.
3. The falsified medicinal product has a batch number 786627 printed on labels with manufacturing date on Aug 2016 and expiry date on Aug 2019. The falsified product closely imitates the genuine registered Augmentin 625mg in many features and it is difficult to differentiate between the two. The key features which distinguish the falsified medicine from the genuine one are as described below:-

   NO.	DESCRIPTION	FALSIFIED MEDICINE - AUGMENTIN 625MG	GENUINE MEDICINE - AUGMENTIN 625MG
   3.1	Information on batch number, manufacturing and expiry dates.	Written by ink	Embossed
   3.2	Information on manufacturing company.	Manufactured by SmithKline Beecham Limited, Worthing, UK.	Manufactured by SmithKline Beecham Limited, Clarendon Road, Worthing, West Sussex, BN14 8QH, United Kingdom

4. This falsified medicine was also confiscated in Uganda and confirmed falsified by the Uganda National Drug Authority (NDA). So far, TMDA has confiscated only one box of 14 tablets which was being sold in Morogoro region.
5. With this notice, the general public is urged to scrutinize the features presented in the packaging boxes carefully in order to avoid purchase or use of the stated falsified medicine.
6. Individuals, retailers and wholesalers who unknowingly possess the falsified batch 786627 of “Augmentin 625mg” tablets are required to take them back to where they have been purchased from or surrender them to any of the TMDA zone offices in Dar es Salaam, Arusha, Mwanza, Mbeya, Mtwara, Simiyu, Tabora and Dodoma or any nearby district or regional hospital.
7. Nonetheless, it should be noted that only one batch (i.e. 786627) has been confirmed to be falsified while other batches circulating on the market are genuine and they can continue to be used for the treatment.
8. The public is further encouraged to report any suspected substandard or falsified medicine, medical devices and diagnostics or any person who engage in clandestine manufacturing and illegal marketing of the regulated products.
9. TMDA will continue to strengthen regulation of medicines, medical devices and diagnostics in order to protect public health.