The National Agency for Food and Drug Administration and Control (NAFDAC) has discontinued the registration of Multi-Dose Anti-Malarial (Artemether/Lumefantrine) dry powder for oral suspension due to concerns over the instability of the reconstituted formulations. The decision, announced in Public Alert No. 01/2025 released on the agency’s website on Thursday, aims to prevent potential health risks associated with the product.
According to the alert, stability studies have shown that the reconstituted Artemether/Lumefantrine oral suspension loses efficacy over time, which could lead to worsening health conditions, increased risks of complications, treatment delays, or even death.
The suspension applies to all locally manufactured and imported Multi-Dose Artemether/Lumefantrine dry powder for oral use. NAFDAC will no longer accept new applications, renewals, or variations for this product.
The agency has directed all zonal directors and state coordinators to conduct surveillance activities and remove all affected products from circulation. Importers, distributors, retailers, healthcare professionals, and caregivers have also been advised to cease the importation, distribution, and sale of the product immediately.
NAFDAC urged healthcare professionals and consumers to report any suspected sale of these products, as well as any substandard or falsified medicines, to the nearest NAFDAC office. The public can also report adverse events or side effects through the agency’s E-reporting platforms or via the Med-safety application available on Android and iOS.
The alert will be uploaded to the World Health Organisation’s (WHO) Global Surveillance and Monitoring System (GSMS) to ensure global awareness and coordination.
This decision underscores NAFDAC’s commitment to safeguarding public health by ensuring the safety and efficacy of medicines available in Nigeria.
