Rwanda Food and Drugs Authority (FDA) has temporarily banned the sale and use of Unibrol (Aminosidine Sulphate) USP 250 mg tablets, citing quality concerns.
Manufactured by Universal Corporation Ltd, Kenya-the medicine is a type of antibiotic that has been administered by mouth in the treatment of intestinal infection, including amoebiasis among humans.
The latest temporary ban follows the November 29, 2020, move by FDA where it recalled two batches of the drug in question with No 5806898 and 5806675 after laboratory test results pointed to quality concerns.
Persisted complaints from local retail pharmacies and clients, which revolve around quality issues on the other batches of the same drug have now forced the regulatory body to suspend the drug pending investigations.
FDA said in a statement date January 12, 2020 the complaints revolved around some tablets in the same pack changing colour from white to yellow
FDA said that it is from this background that all batches of the tablets on the Rwandan market are recalled to pave way for a deeper investigation.
Lazare Ntirenganya, Division Manager for Pharmacovigilance and Safety Monitoring at Rwanda FDA told The New Times that changing colour for tablets in the pack implies that the drug falls short of quality standards, indicating that normally, the colour of those tablets is white.
"As the entity in charge ensuring that people get quality medicines that are safe to their health, we decided to suspend all the batches of the drug on the Rwandan market as we carry out a deep investigation on it," he said.
The Authority instructed all importers, central medical stores, wholesalers, district pharmacies, retailers, public and private health facilities in possession of those tablets to quarantine all quantities in their stores until the investigation will be carried out.
The importation of those tablets is suspended until further notice, FDA stated.