Rwanda Food and Drugs Authority (RFDA) has recalled batches of Fluconazole 200mg tablets manufactured by Universal Corporation (UCL) Ltd /Kikuyu, Kenya.
The voluntary recall from all retails and facility level was announced this January 3, following an earlier notification letter in which the FDA had alerted UCL of the discoloration in the Fluconazole 200mg tablets.
Fluconazole is used to treat serious fungal or yeast infections, including vaginal candidiasis, oropharyngeal candidiasis (thrush, oral thrush), esophageal candidiasis (candida esophagitis), other candida infections (including urinary tract infections, peritonitis [inflammation of the lining of the stomach among others.
The RFDA said that in further reference to an investigation conducted on the drug present on the market showed that some incriminated tablet batches had entered into the Rwandan market.
Four batch numbers of the tablet – which expire January 31 and August 31, 2025, and supposed to look pink in color before that timeline had started turning into the white color, according to the investigation details.
For consumer precaution, the batches are 5810315, 5810316, 5811390 and 5810022.
In a communique, RFDA instructed all importers, central medical stores, wholesale dealers, retailers and all health facilities to stop the distribution of the drugs and return them to the suppliers.
The RFDA also stated that the importers and suppliers of the above medication have up to 10 days (from date of announcement) to report these imported quantities, distributed, returned and the final stock in hand.
RFDA Notice letter Jan 2024
Part of RFDA Jan 2024 notice
