Rwanda suspends Kenyan-made paracetamol over quality issues

A close view of the particles that FDA says were found in the drug/Courtesy

The Rwanda Food and Drugs Authority (FDA) has suspended a Kenyan-made Paracetamol drug over quality issues and ordered actors in the pharmaceutical sector to recall stock as more investigations are being undertaken.

The paracetamol drug goes by the brand “Totomol 120mg/5ml” and it is manufactured by Laboratory & Allied Limited, a Kenyan pharmaceutical company that supplies generic medicines to the private market, governmental institutions, local and international NGOs and regional export markets.

The drug is in form of a suspension (a medicine composed of liquid mixed with small pieces of drug).

In a statement released Wednesday, the FDA said that the drug in question was found with particulate matter in it, a quality issue that prompted the regulatory institution to take action, “referring to the spontaneous reports from clients, retail pharmacies and further investigation conducted by Rwanda FDA, where paracetamol suspension 120mg/5ml (Toto-moL®) was found with particulate matters in the suspension,” the statement read.

In an interview with The New Times, Dr. Charles Karangwa the Director-General of the FDA said that for a drug to have such matter in it is an indication that it has a quality issue that should be cautiously investigated.

As the FDA is undertaking more investigations, it has among other actions ordered that the batch of the drug in question be recalled within five calendar days by the responsible actors in the country, as well as urging health institutions in possession of the breached batch “to stop distribution, dispensing and return the drug to their suppliers.

The communiqué was directed at district pharmacies, district hospitals, referral hospitals, retail pharmacies, private clinics and copied to the Ministry of Health and the Rwanda Biomedical Centre.

The regulatory institution also Rwanda instructed all importers “to provide a report on the quantities imported, distributed, returned and stock on hand within 5 calendar days.”

In an interview with The New Times, Julio Marios Musangwa, a pharmacist at Pharmacie Conseil in Kigali said that for a drug to have crystals in it may mean that it has impurities,

“Having crystals in a drug may more or less mean there that are impurities in it. These impurities can be of different elements that can harm the normal human cells,” he said.

According to Karangwa, the FDA has had complaints from consumers concerning the drug in question, something that the FDA itself found to be true after having done its own examination on the drug.


Some of the Totomol drugs that were investigated by the FDA/Courtesy

Karangwa said that inspection is being carried out in different parts of the country to see that the drug is quarantined as more investigations are being done.

The incident follows a recent recall of different foodstuffs made in Kenya from the Rwandan market by the Rwanda FDA, on recommendation from their counterparts; the Kenya Bureau of Standards (KEBS).

The products which included Kenyan-made peanut butter and maize flour were found to have high levels of Aflatoxins, which are poisonous carcinogens that are produced by certain molds that grow in soil, decaying vegetation, hay, and grains.