Rwanda recalls Kenya-made antifungal drug over quality concerns

Rwandese Food and Drug Authority has called for the recall of fluconazole tablets manufactured in Kenya on grounds of discolouration.

The Authority said in a statement posted on social media X it has called for the immediate stoppage of distribution of Fluconazole 200 milligram (mg) tablets by Universal Corporation Limited from Kikuyu, Kenya.

Some batches of the drug were said to have changed colour which resulted in the recall.

"Based on the statement number UCL/PD/pp/2023/05/043 of the Universal Corporation Ltd notifying the suspension of certain numbers (batches) of the medicine called Fluconazole 200mg tablets produced by the factory, as a result of the tablets changing colour," said Rwanda FDA in a statement shared in Rwandese (this is the translation).

"Based on the inspection conducted in Rwanda, the FDA confirmed that some numbers of fluconazole 200 mg were suspended from entering the Rwandan market."

The letter highlights that the suspension was voluntary after UCL was notified of the discolouration of the tablets, and an inspection was carried out by RFDA that led to the recall.

The four batches said to discolour were batch numbers; 5810315, 5810316, 5811390 and 5810022.

Fluconazole is used to treat serious fungal or yeast infections.

The FDA urged all drug importers and pharmacies in Rwanda to stop supplying and selling the drug number of the drugs highlighted above and to return them to their place of origin.

UCL is a Kenyan Pharmaceutical Manufacturing Company based in Kikuyu Township, Kiambu County on the outskirts of the capital city Nairobi.

The RFDA said those who import fluconazole are required to submit a report which includes the quantities they have, or sold, those who returned the drugs or those who are holding them in stock within ten days from the December 29 notice date.

The authority did not mention whether the drug has had any effect on the citizenry despite the recall on safety concerns.

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