This archive report was first published on 21 November 2019.
On November 20, 2019, the Rwandan Food and Drug Authority (FDA) issued a statement recalling Totomol, a painkiller made in Kenya for babies, from the Rwandan market.
The paracetamol suspension 120mg/5ml (Totomol) was found to contain particulate matter, prompting the FDA to instruct all importers, central medical stores, wholesale pharmacies, district pharmacies, retail pharmacies, public and private health facilities in possession of the said drug to stop its distribution, dispensing and return the drug to their suppliers.
“Rwanda FDA instructs all importers, central medical stores, wholesale pharmacies, district pharmacies, retail pharmacies, public and private health facilities in possession of the said drug to stop its distribution, dispensing and return the drug to their suppliers,” FDA said.
Totomol is produced by Laboratory & Allied Limited, a Kenyan pharmaceutical company. The company's batch number 73718, which was exported, is affected by the recall.
According to Dr. Simon Muigai, the Company Pharmacist, the batch was manufactured in February this year and its expiration date is indicated as January 2022.
Julio Marios Musangwa, a pharmacist in Kigali, explained the quality issues that led to the suspension of Totomol, which retails at Ksh. 46. “Having crystals in a drug may more or less mean there are impurities in it. These impurities can be of different elements that can harm the normal human cells,” Musangwa said.
