Rwanda recalls Kenyan-made anti-fungal cream over quality

Rwanda has recalled a Kenyan-made anti-fungal cream following complaints of poor packaging that damages its quality standard.

In a statement on Monday, the Rwanda Food and Drugs Authority (FDA) said that Ketoconazole (Kenazole) Cream USP 2%w/w—used for the treatment of fungal and yeast infections—had been packaged poorly.

“Referring to the spontaneous reports from the clients, retail pharmacies and further investigation conducted by the Rwanda FDA, where Ketoconazole Cream 2% was found poorly packaged where it gets out of its package while in storage,” said Dr Charles Karangwa, the acting director-general of Rwanda FDA.

According to the statement, the recalled drug, batch number 1907205 of 07/2019 and expiry date of 06/2022 is manufactured by Dawa Ltd Kenya and imported into Rwanda by Abacus Pharma (A) Ltd.

“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.

He further instructed all importers and the distributors of the cream to report on quantities distributed, returned quantities and available stock within 10 working days.

Ketoconazole cream is prescribed for several types of fungal infections including ringworm, athlete's foot, jock itch, thrush infections of the skin and vagina, and skin conditions.

Last year Rwanda recalled paracetamol syrup imported from Kenya following complaints of particles found in the medicine.

FDA at the time indicated that Paracetamol Suspension 120 mg/5ml (Toto-moL®️) that is generally made for children had been banned.