FALSIFIED ZIDOLAM-N

PUBLIC ALERT – FALSIFIED ZIDOLAM-N

(LAMIVUDINE, ZIDOVUDINE & NEVIRAPINE) TABLETS- USED AS ANTI- RETROVIRAL MEDICINE FOUND IN KENYA.

Reference is made to the presence of the above falsified medicine in Kenya. The Pharmacy and Poisons Board, the Medicines Registration Authority in Kenya, has been working closely with the World Health Organization (WHO) and Program Partners in investigating the same. On the 13th September 2011 we identified the presence of discolored, moulding and easilybreaking Zidolam-N in Nairobi being distributed through an NGO that supports HIV care in Kenya. Investigations into the same have revealed that:

1. The Zidolam-N has been manufactured in India by Hetero Drugs Ltd and is duly registered in Kenya since 2007
2. Batch number E100766 with a manufacture date of November 2010 and expiry date of October 2013 has been found to have the above mentioned quality defects. Similarly another batch number A9366 manufactured in June 2009 and an expiry on May 2012 has been identified to be having the same problem.

3. Institutions that have received the above named batches have been informed to quarantine and not dispense the same to any patient with immediate effect, as further investigations were taken.

A comparison of the falsified product is provided herewith for ease of identification: Click Here

Considering the fact that this product which has been prequalified by WHO and the said batches were only supplied through one program / partner in Kenya, the known patients who have received these batches have already been contacted to return their stocks for a replacement. This product is not expected to be available in the private sector, nevertheless, the public is informed that any Zidolam-N in their possession with the above mentioned batch numbers should be taken back to your point of purchase / receipt immediately.

Samples of the products have been sent to several laboratories for detailed chemical analysis,whose findings are expected early next week.
Health care professionals are advised to:

1. Ensure patients are not dispensed with these aforesaid batches
2. Those who have received the same should be asked to return immediately
3. Treatment regimens dependent on this product should not be stopped indiscriminately.
The PPB wishes to reassure all that it is carrying out in-depth investigations into this falsification. More information will be supplied as reports of analysis and further inspections arrive. One can also refer to the article on the WHO website:

Download Info on Falsified ZidolamN
(Source: http://apps.who.int/prequal/info_press/documents/Falsified_ZidolamN_23September2011.pdf)

For any further clarification on this matter, please contact:

The Registrar
Pharmacy and Poisons Board
Nairobi
Tel: 020-356 2107 / 0733 88 44 11 / 0720 60 88 11
E-mail: jwasike@pharmacyboardkenya.org

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