- Rwanda Food and Drugs Authority (FDA) summarily banned the Paracetamol Suspension 120 mg/5ml (Toto-moL®) that is generally made for children.
- This follows complaints of particles being found in the baby medicine.
- The paracetamol drug is manufactured by Laboratory & Allied Limited, a Kenyan pharmaceutical company.
The Kenyan pharmaceutical industry has suffered a ‘Public Relations’ blow after Rwanda decided to recall paracetamol syrup imported from Kenya.
This follows complaints of particles being found in the baby medicine. The paracetamol drug 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.
“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,” Julio Marios Musangwa, a pharmacist at Pharmacie Conseil in Kigali told The New Times.
Some of the Totomol drugs that were investigated by the FDA/Courtesy
Following the investigations, Rwanda Food and Drugs Authority (FDA) issued a statement summarily banning the Paracetamol 120 mg/5ml (Toto-moL®) that is generally made for children.
“Referring to the spontaneous reports from the clients, retail pharmacies and further investigation conducted by the Rwanda FDA, where Paracetamol Suspension 120 mg/5ml (Toto-moL®) was found with particulate matters in the suspension,” Dr Charles Karangwa, the Acting director-general of Rwanda FDA, said in the statement.
According to the statement, the drug, batch number 73718, was manufactured by Kenyan Laboratory & Allied Ltd earlier in February.
“Rwanda Food and Drug Authority instructs all importers, central medical stores, wholesale pharmacies, district Pharmacies, retail pharmacies, Public and Private health facilities in possession of the incriminated batch to stop distribution, dispensing and return them to their suppliers,” Dr Karangwa said in the statement.
Pharmacy and Poisons Board.
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.
Dr Karangwa instructed all importers to submit reports, within five working days, on imported, distributed, returned quantities and available quantities of each brand.
The latest ban comes just six months after Rwanda banned Albendazole and Mebendazole drugs due to the low efficacy of single-dose for the treatment of hookworm.
The incident also 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.