The Rwanda Food and Drug Authority (FDA) has recalled Kenyan-manufactured Paracetamol suspension 120mg/5ml of trade name Totomol from the market after it was found to contain crystals.
In a statement released by the Director General, the Rwanda FDA was acting on complains from clients and retail pharmacies over particulate matter in the syrup meant for babies. Their tests confirmed presence of particulate matter hence warranting the recall of the drug.
“Rwanda FDA instructs all importers, central medical stores, whole sale pharmacies, district pharmacies, retail pharmacies, public and private facilities in possession of the said drug to stop its distribution, dispensing and return the drug to their suppliers”, read the FDA statement.
The authority gave a 5-day window for suppliers, distributors and retailers to return the product.
What does this mean?
Totomol is a drug containing paracetamol that is manufactured in Kenya by Kenyan pharmaceutical company Laboratory and Allied Limited.
Particulate matter in a syrup or suspension is a sign that the product is of poor quality. It is, therefore, likely to have been contaminated. These particulate matter could pose a health risk to the product users and are often regulated during manufacturing of drugs/medicines.
The company pharmacist Dr Simon Muigai has confirmed that they have received communication about the suspension of the drug.
“We wish to confirm that only the batch 73718 that was exported to Rwanda had issues and that we have dully informed the Pharmacy and Poisons Board (PPB) about it”, he said.
No such reports have been noted about the Totomol distributed locally in Kenya.
Bad name for Kenya
Other products from Kenya that have been recently flagged off for their contamination and potential health risks include different brands of maize flour and peanut butter products. This puts the country’s regulatory bodies on the spot light for poor regulation and dents the image of the country.