The Rwanda Food and Drugs Authority (RFDA) has initiated a voluntary recall of Fluconazole 200mg tablets produced by Universal Corporation (UCL) Ltd. in Kikuyu, Kenya. The recall encompasses all retail and facility levels, and it was officially announced on January 3, following a prior notification letter from the FDA to UCL regarding discoloration issues observed in the Fluconazole 200mg tablets.
RFDA disclosed that four bulk batches of pink Fluconazole 200mg tablets, which were imported into Rwanda, exhibited white discoloration shortly after their manufacture. The tablets, identified by four batch numbers and slated to expire on January 31 and August 31, 2025, were expected to maintain a pink color until the specified timelines but had transitioned to white prematurely.
In response, the RFDA has directed all importers, central medical stores, wholesalers, RMS branches, retailers, and both public and private health facilities to cease the distribution of the affected Fluconazole 200mg tablet batches. The statement issued by the RFDA emphasizes the necessity for these entities to return the recalled batches to their respective suppliers for proper management.
Fluconazole, utilized in the treatment of severe fungal or yeast infections such as vaginal candidiasis, oropharyngeal candidiasis (thrush), esophageal candidiasis, and other candida infections, demonstrated an unexpected discoloration issue in the identified batches. The RFDA, in the course of an investigation into the presence of the drug on the market, determined that the implicated tablet batches had indeed entered the Rwandan market.
Importers and suppliers of the affected medication are given a 10-day window, from the date of the official announcement, to report the imported quantities, distribution details, returns, and the remaining stock on hand to the RFDA.
While the Kenyan Ministry of Health has not provided information on the recall status of the drug from hospitals and chemists in Kenya, there are no reports of the pink tablets displaying discoloration in the Kenyan market as of now.
