The National Agency for Food and Drug Administration and Control (NAFDAC) has halted  the registration of Multi-Dose Anti-Malarial (Artemether/Lumefantrine) dry powder for oral suspension.

The announcement was made in a public alert No. 01/2025, released on the agency’s website yesterday.

NAFDAC explained that the decision was made due to the instability of the reconstituted formulations, which could lead to a loss of efficacy over time.

According NAFDAC, 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.”

According to the Agency, stability studies revealed that reconstituted Artemether/Lumefantrine oral suspension becomes unstable after mixing, leading to a loss of efficacy.

“This loss can have severe health consequences, including treatment failure, increased risk of complications, and, in extreme cases, death.” the agency stated. 

The alert also revealed that NAFDAC had directed all zonal directors and state coordinators to carry out surveillance activities and remove all locally manufactured and imported products from circulation.

It further advised importers, distributors, retailers, healthcare professionals, and caregivers 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 its nearest office.

The agency said the public could 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.

NAFDAC added that this alert would be uploaded to the World Health Organisation’s (WHO) Global Surveillance and Monitoring System.