The Rwanda Food Drugs Authority (RFDA) has issued a recall for specific batches of drugs produced in Kenya. In an announcement on Wednesday, January 3, the authority highlighted the safety concerns surrounding Fluconazole 200mg tablets manufactured in Kikuyu, Kenya.
Consequently, the RFDA has instructed all public and private health facilities to cease the sale and distribution of the mentioned drug.
The statement from the RFDA includes an instruction for importers, central medical stores, wholesalers, RMS branches, retailers, as well as public and private health facilities to halt the distribution of the identified batches of Fluconazole 200mg tablets.
The directive emphasizes the need to return these batches to their suppliers for proper management, as outlined in the statement.
Further, the RFDA indicated that it had written to the Kenyan based company regarding the concern.
Additionally, the report detailed that the first batch of the pink Fluconazole 200mg tablets with an expiry date of January 31, 2025, displayed white discoloration.
At the same time, another batch of the pink set to expire on January 31, 2025, displayed white discoloration, according to the authority.
Likewise, the third batch of the Kenyan made drug meant to expire on August 31, 2025, also displayed white discoloration an anomaly that was also seen in the last imported batch.
“Reference is also made to the letter with ref. No UCL/PD/pp/2023/05/043 by Universal Corporation Ltd notifying the recall of Fluconazole 200mg due to discoloration of tablets.
“Further reference is made to the investigation performed by Rwanda FDA which confirmed that some incriminated batches were imported into Rwanda,” noted RFDA.
ACTION TO BE TAKEN
Rwanda FDA therefore instructed 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 the drugs.
Additionally, the RFDA directed the importers and suppliers of the batches in question of fluconazole 200mg tablets to report to Rwanda FDA within 10 days from the date of publication of the recall.