The Rwanda Food Drugs Authority (RFDA) on Wednesday, January 3, announced its decision to recall an antifungal drug produced in Kikuyu, Kenya. The RFDA directive focused on the withdrawal of specific batches of Fluconazole 200mg tablets imported into the country from Kenya.
The recall came after the Authority previously notified the Kenyan manufacturer about discoloration issues identified in the Fluconazole 200mg tablets.
Fluconazole Capsules are used to treat infections caused by fungi. They may also be used to stop people from getting a candidal infection. The most common cause of fungal infections is a yeast called Candida.
RFDA revealed that four bulk batches of pink Fluconazole 200mg tablets, upon their importation, displayed white discolouration within a short shelf life.
“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 recall statement reads in part.
Moreover, importers and suppliers dealing with the drug were asked to communicate with RFDA within ten days from the recall date.
Health officials and authorities in Rwanda intend to gather information from these entities regarding the quantities of the fluconazole 200mg tablets distributed. This data will assist the government, in understanding the adverse effects the drug might have had on Rwandans.
Additionally, the importers and suppliers were requested to furnish the Health Ministry with details regarding quantities returned and the remaining stocks on hand.
It’s notable that in February 2020, Rwanda also banned Kenyan-made azithromycin dry suspension 200 mg/5ml (Zerocin) due to reported complaints from users.
Azithromycin is used to treat a wide variety of bacterial infections. It is a macrolide-type antibiotic. It works by stopping the growth of bacteria.
