NAFDAC Halts Registration of Artemether/Lumefantrine Oral Suspension
The National Agency for Food and Drug Administration and Control (NAFDAC) has stopped the registration of Multi-Dose Anti-Malarial (Artemether/Lumefantrine) dry powder for oral suspension due to concerns over its stability after reconstitution.
In a public alert (No. 01/2025) issued on Thursday, NAFDAC cited that the formulation loses efficacy over time, which could lead to treatment failure and increased health risks.
The suspension applies to both locally manufactured and imported versions of the product, and NAFDAC will no longer process new applications, renewals, or modifications for its registration.
Health authorities have been instructed to remove the product from circulation, while importers, distributors, and retailers have been directed to immediately stop its sale and distribution.
NAFDAC also urged healthcare professionals and consumers to report any sale of the product or cases of substandard or falsified medicines through its E-reporting platforms or the Med-Safety app.
Additionally, this alert will be shared with the World Health Organisation’s (WHO) Global Surveillance and Monitoring System (GSMS).
