This decision was communicated in a public alert No. 01/2025, which was published on the agency’s website on Thursday. The alert indicates that the action was taken due to the instability of the reconstituted formulations, which may result in diminished efficacy over time.
The suspension affects all Multi-Dose Artemether/Lumefantrine dry powder for oral use, whether locally produced or imported. NAFDAC will no longer process new applications, renewals, or modifications for this product.
The alert further explains that stability studies have demonstrated that the oral suspension becomes unstable once reconstituted, potentially leading to a loss of effectiveness. This situation could exacerbate health issues, increase the risk of complications, cause treatment delays, or even result in fatalities.
NAFDAC has instructed all zonal directors and state coordinators to conduct surveillance and ensure the removal of all affected products from the market.
The agency has also urged importers, distributors, retailers, healthcare professionals, and caregivers to immediately stop the importation, distribution, and sale of this product.
Healthcare professionals and consumers are encouraged to report any suspected sales of these products, as well as any substandard or counterfeit medications, to the nearest NAFDAC office.
Additionally, the public can report adverse events or side effects through the agency’s E-reporting platforms or the Med-safety application available on both Android and iOS.
NAFDAC has stated that this alert will be shared with the World Health Organisation’s (WHO) Global Surveillance and Monitoring System (GSMS).