Rwanda FDA recalls fluconazole due to quality concerns

RWANDA — The Rwanda Food and Drugs Authority (RFDA) has recalled batches of Fluconazole 200mg tablets manufactured  by Universal Corporation (UCL) Limited from its outlets. 

This voluntary recall from both retail and facility levels was announced on January 3, after a previous notification letter in which the FDA informed UCL of the discolouration in the Fluconazole 200mg pills.

According to the RFDA, four bulk batches of pink Fluconazole 200mg tablets imported into Rwanda, 5810315, 5810316, 5811390, and 5810022, exhibited a white discolouration.

The four batch numbers of the tablet that are set to expire between January 31 and August 31, 2025, and anticipated to be pink in colour before this timeline had began to change into the white colour.

Following this disclosure, the RFDA has directed all importers, central medical stores, wholesalers, RMS branches, retailers, and public and private health facilities to halt distribution of the batches of fluconazole 200mg tablets and return them to their suppliers for correct management.

Furthermore, all importers and suppliers are required report to the RFDA within 10 days and provide the Health Ministry with information on the quantities imported, amounts distributed, quantities returned, and final stocks on hand.

Fluconazole is used to treat serious fungal or yeast infections such as vaginal candidiasis, oropharyngeal candidiasis (thrush, oral thrush), oesophageal candidiasis (candida esophagitis), and other candida infections such as urinary tract infections and peritonitis (inflammation of the stomach lining, among other things).

Fluconazole can also be used to prevent candidiasis in individuals undergoing cancer or radiation treatment who have bone marrow transplants.

Fluconazole medication works by either killing or preventing the growth of fungus or yeast.

Kenyan authorities are yet to say whether the medicine, which is used to treat fungal or yeast infections, would be withdrawn from the Kenyan market.

In February 2020, Rwanda also banned Kenyan-made azithromycin dry suspension 200 mg/5 ml (Zerocin) following what they termed multiple complaints from users.

However, product recalls are widespread in countries around the world to safeguard local consumers. In August of last year, the US Consumer Product Safety Commission (CPSC) recalled over 100,000 pairs of baby jeans made in Kenya due to metal snaps that could hurt infants.

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