The National Agency for Food and Drug Administration and Control (NAFDAC) has officially discontinued the registration of Multi-Dose Anti-Malarial (Artemether/Lumefantrine) dry powder for oral suspension due to concerns over its stability and effectiveness.
The agency announced the decision in Public Alert No. 01/2025, released on its website on Thursday, stating that studies revealed the reconstituted formulation becomes unstable over time, leading to a loss of efficacy.
As a result, NAFDAC will no longer accept new applications, renewals, or variations for the product, which applies to both locally manufactured and imported versions of the drug.
The agency warned that the instability of the oral suspension could result in worsening health conditions, increased risks of complications, treatment failure, or even death.
To mitigate these risks, NAFDAC has directed all zonal directors and state coordinators to carry out surveillance operations and remove the product from circulation.
Healthcare professionals, importers, distributors, and retailers have been advised to immediately cease the importation, sale, and distribution of the affected medication.
According to NAFDAC, the alert will also be uploaded to the World Health Organization’s (WHO) Global Surveillance and Monitoring System (GSMS) to ensure global awareness of the development.
Additionally, NAFDAC urged the public to report any sightings of the product or any suspected substandard or falsified medicines through its E-reporting platforms, the Med-Safety app (available on Android and iOS), or the nearest NAFDAC office.
