The National Drug Authority (NDA) mandated with the responsibility of ensuring that the population accesses medicines that are of good quality, safe and efficacious, wishes to inform the general public that it has received information from World Health Organization of a COUNTERFEIT ZIDOLAM-N TABLETS on the Kenyan market. Zidolam-N tablets are normally taken by HIV/AIDS patients. The counterfeit Zidolam-N tablets tablets – have a reference to "batch number E100766", and claiming to be manufactured in November 2010, with an expiry date of October 2013.
NDA therefore informs the health service providers, patients and care givers to look out for the following ZIDOLAM-N TABLETS features to differentiate between the genuine from counterfeit.
Genuine Zidolam-N (HA275) productbatch number E100766
The folding of the secondary (box) packaging materials is of good quality.
The printing on the bottle label displays uniform black and colour printing, in a uniform font.
One font style is used for the printing of the batch code number; zero is printed as 0.
The background colour of the label is of a uniform light green.
The spacing between the printed license number and the printed batch code number on the bottle label is constant in all samples.
The samples of the genuine Hetero batch do not carry a COIP logo.
All tablets are of a clear white, devoid of friability, discolouration or moulding.
The secondary packaging materials are of poor quality, with faulty folding
The printing on the bottle label is of varying colour (from blue-gray to black) and uses more than one font style.
The printing of the batch code number varies: sometimes the zero number appears as 0, and sometimes as Ø.
The background colour of the label shows different shades and is darker in colour than that of the genuine product.
The spacing between the printed license number and the printed batch code number on the bottle label varies from one bottle to another.
The samples of the counterfeit batch bear the COIP logo, in varying shades of blue. (The logo is that of a Canadian nongovernmental organization which states that it was not involved in the procurement or distribution of this product. Investigation into the supply chain continues.) discolouration or moulding.
The tablets in some of the bottles show clear friability issues, including change of colour due to discolouration and moulding.
NDA also informs the public that the GenuineZidolam-N tablets is registered for use in Uganda, andtherefore requests health professionals, HIV/AIDS patients and care providers to be vigilant to avoid use of the counterfeit Zidolam-N tablets.
NDA appeals to you all to report the existence of the counterfeit Zidolam-N tablets and for more information contact Head Drug Inspectorate Services on 0414 258844.
NDA Mission:
To ensure quality, safety and efficacy of human
and veterinary medicines and other health care
products through the regulation and control of
their production, importation, distribution and
use.