The Rwanda National Food and Drug Authority, the government’s agency that protects and regulates medical products and processed foods has recalled Broncalene, a syrup commonly known for healing dry cough.
The ban is hinged on safety and health concerns.
The ban on the market follows a study carried out by the French pharmaceutical agency that decided to recall the product after finding that its active ingredient “pholcodine” has a higher risk of causing anaphylactic allergic when the consumer is given surgical-related medicine.
According to the FDA statement, all importers, wholesalers, and retailers both public and private health facilities are obliged to stop distributing medicine, and recalled products are supposed to be returned to the suppliers for proper management.
“Those imported the products from the country are supposed to give a report indicating quantities imported and quantities distributed and quantities returned within 15 days,” FDA said in a statement.
Both adult and infant versions of Broncalene syrups in the supply chain are supposed to be recalled on the market with immediate effect.
The medication was recommended to soothe dry coughs and irritable coughs particularly when they occur during the night.
One of the common side effects of the medicine included vomiting, nausea, and Bronchospasm.
Dryness of the mucous membranes, constipation and drowsiness and reduced alertness are marked when treatment begins.
The European Medicine Agency is reviewing the other medicine with pholcodine ingredients.
