The National Agency for Food and Drug Administration and Control (NAFDAC) has discontinued the registration of Multi-Dose Anti-Malarial (Artemether/Lumefantrine) dry powder for oral suspension due to concerns over its stability and efficacy.
In a public alert released on its website, NAFDAC stated that reconstituted formulations of the drug were found to be unstable, leading to potential loss of effectiveness over time. As a result, the agency will no longer accept new applications, renewals, or variations for this product, whether locally manufactured or imported.
The agency warned that the instability of the suspension could cause treatment failure, worsening health conditions, and increased risks of complications, including death. To address this, NAFDAC has directed its zonal directors and state coordinators to conduct surveillance and remove all affected products from circulation.
Importers, distributors, retailers, healthcare professionals, and caregivers have been instructed to halt the importation, distribution, and sale of the product immediately. Consumers and healthcare providers are encouraged to report any continued sale of the product, as well as any suspected substandard or falsified medicines, to NAFDAC offices or through the agency’s e-reporting platforms and Med-safety app.
The agency emphasized its commitment to ensuring the safety and effectiveness of medications available to Nigerians and urged the public to comply with the directive.
