TANZANIA—The Medicines and Medical Devices Authority (TMDA) has clarified the status of the antifungal tablets Fluconazole 200mg manufactured by the Kenyan company (Universal Corporation) following health concerns raised in Rwanda.
TMDA noted that it has received a notification from the Rwanda Food and Drug Authority (RFDA) on the availability of substandard Fluconazole 200mg tablets manufactured by the Kenyan company in its market on December 29, last year.
The faulty medication was discovered with the serial numbers 5810315, 5810316, 5811390, and 5810022, and its expiration date is August 2025.
In a notice on January 3, the RFDA urged all importers, central medical stores, wholesalers, RMS branches, retailers, and public and private health facilities to suspend distribution of the batches of fluconazole 200mg tablets and return them to their suppliers for proper management.
The discolouration of the Fluconazole 200mg tablets, according to the RFDA, highlighted quality problems since the four batch numbers of the tablet are slated to expire between January 31 and August 31, 2025, and were expected to be pink in colour before this timeline had begun to turn into the white colour.
TMDA has confirmed to the public that it has not registered such pills but had instead registered the company’s Fluconazole 150mg and 200mg capsules, according to a portion of its press release.
It also stated that it has not provided a permit for the importation of such drugs into the country, noting the possibility of illicit means of smuggling such medicines across unofficial borders.
Furthermore, TMD stated that the RFDA’s action was taken to comply with the World Health Organization’s (WHO) requirements to report the presence of substandard and counterfeit drugs, allowing other Drug Regulatory Authorities worldwide to take appropriate action if these versions are distributed in their countries.
In Rwanda, the RFDA called for the recall of Fluconazole 200mg at both retail and facility levels by the FDA due to the discolouration in the Fluconazole 200mg pills.
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.
The Tanzania Medicines and Medical Devices Authority (TMDA) is a government entity formed under Section 4(1) of the Medicines and Medical Devices Act, Chapter 219.
The Authority is in charge of protecting public health by regulating the quality, safety, and efficacy of medicines, medical equipment, and diagnostics.