Rwanda recalls Kenyan drug over quality fears

Kenya is on the spot after Rwanda Food and Drug Authority (RFDA) recalled a specific batch of Fluconazole 200mg tablets imported from a local pharmaceutical company.

It said the decision was made following the discovery of white discolouration in four bulk batches of the pink Fluconazole tablets manufactured by the Kikuyu-based Universal Corporation Limited, which raised concerns about their quality and safety.

In a statement released by RFDA, the regulatory body urged all stakeholders in the pharmaceutical supply chain, including importers, central medical stores, wholesalers, RMS branches, retailers, and public and private health facilities, to immediately halt the distribution of the affected Fluconazole tablets.  The statement emphasized the importance of returning the identified batches to their respective suppliers for proper management.

“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,” stated the release.

Quantities returned

For accountability and proper handling of the situation, RFDA has mandated that all importers and suppliers must report back to the regulatory authority within 10 days from the date of the recall announcement.  These reports are required to include detailed information on the quantities returned and the final stocks still on hand.

The recall has sparked attention given the Kenyan Health Ministry had not issued a statement regarding whether the same batch of Fluconazole tablets would be recalled from the Kenyan market.

Swift and transparent response by RFDA underscores its commitment to ensuring the safety and efficacy of pharmaceutical products circulating in the country.  It said the decision to recall the Fluconazole tablets is in line with international best practices and serves as a precautionary measure to protect the health and well-being of the Rwandan population.

Fluconazole is commonly used to treat fungal infections and is an essential medication in healthcare settings.

Any compromise in its quality, as indicated by discolouration, raises serious concerns about the potential impact on patient health. The recall not only addresses the immediate issue of the affected batches but also demonstrates the RFDA’s dedication to maintaining high standards in the pharmaceutical sector.

Stakeholders in both Rwanda will be closely monitor the response from Kenya and the pharmaceutical company involved.  The incident highlights the interconnectedness of pharmaceutical markets in the region and the importance of rigorous quality control measures to safeguard public health.

The RFDA’s proactive approach serves as a model for effective regulatory oversight in the face of potential health risks, reinforcing the importance of collaboration between regulatory authorities, pharmaceutical companies, and healthcare providers to uphold the highest standards in drug safety and efficacy.

In 2020, Rwanda also recalled a Kenyan-made anti-fungal cream following complaints of poor packaging that damages its quality standard.

Poorly packaged

The regulator had said that Ketoconazole (Kenazole) Cream USP 2%w/w—used for the treatment of fungal and yeast infections—had been packaged poorly.

“Referring to the spontaneous reports from the clients, retail pharmacies and further investigation conducted by the Rwanda FDA, where Ketoconazole Cream 2% was found poorly packaged where it gets out of its package while in storage,” said RFDA.