Rwanda Food and Drugs Authority has barred shops from selling batches of Fluconazole 200mg tablets imported from Kenya.
In a notice dated Wednesday, January 3, the authority also directed the importers to stop bringing into the country the drug manufactured in Kikuyu, Kenya.
"Rwanda FDA instructs all importers, central medical stores, wholesalers, RMS branches, retailers, Public and Private Health Facilities to stop the distribution of the above-mentioned batches of fluconazole 200mg tablets and return them to their suppliers for proper management,” the notice indicated.
Rwanda further gave the importers a 10-day ultimatum to report back on the quantities shipped back to the Kenyan manufacturer.
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According to the notice, the recall is due to the discolouration in the Fluconazole 200mg tablets.
The authority announced that four bulk batches of pink Fluconazole 200mg tablets imported into the country had a white discolouration after a short shelf life.
Rwanda indicated that the drug posed a danger to the users prompting the recall order.
"Reference is also made to the letter with ref. No UCL/PD/pp/2023/05/043 by Universal Corporation Ltd notifying the recall of Fluconazole 200mg due to the discolouration of tablets. further reference is made to the investigations performed by Rwanda FDA which confirmed that some incriminated batches were imported into Rwanda," the recall notice indicated.
The report that will be issued by the importers will determine the fate of the Kenyan-made drug in Rwanda.
