NAFDAC Orders Stop On Artemether/Lumefantrine Oral Suspension Registration

The multi-dose oral suspension of artemether/lumefantrine dry powder has no longer been registered by the National Agency for Food and Drug Administration and Control (NAFDAC).

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

According to the alert, the decision was made due to the instability of the reconstituted formulations, which can lead to a loss of efficacy over time.

It said 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 alert, stability studies have shown that once reconstituted, the Artemether/Lumefantrine oral suspension becomes unstable, which can result in a loss of efficacy.

The agency said this could lead to worsening health conditions, increased risks of complications, treatment delays, or even death.

It said NAFDAC had directed all zonal directors and state coordinators to carry out surveillance activities and remove all locally manufactured and imported products from circulation.

The agency also advised importers, distributors, retailers, healthcare professionals, and caregivers to cease the importation, distribution, and sale of the product immediately.

It said healthcare professionals and consumers had been urged to report any suspected sale of these products, as well as any substandard or falsified medicines, to the nearest NAFDAC 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 Organization’s (WHO) Global Surveillance and Monitoring System (GSMS). (NAN)