The National Agency for Food and Drug Administration and Control (NAFDAC) has reminded the public that it has discontinued the registration of Multi-Dose Artemether/Lumefantrine dry powder for oral suspension due to safety and efficacy concerns. The reminder comes via Public Alert No. 09/2026, following the original directive issued in February 2025.
According to NAFDAC, stability studies revealed that once reconstituted, the multi-dose suspension becomes unstable, resulting in a significant loss of efficacy. The agency warned that this could worsen malaria infections, increase the risk of complications, delay treatment, and in severe cases, even lead to death.
The directive applies to all locally manufactured and imported Multi-Dose Artemether/Lumefantrine dry powder for oral suspension. NAFDAC confirmed that it will no longer accept new, renewal, or variation applications for these products. Manufacturers are now required to produce safer alternatives, including dispersible tablets or single-dose sachets of powder or granules.
NAFDAC has urged healthcare professionals and consumers to report any suspicion of sale of the banned products, substandard medicines, or falsified medical products. Reports can be made at the nearest NAFDAC office, via the toll-free number 0800-162-3322, or by email at sf.alert@nafdac.gov.ng.
The agency emphasized that the measure is part of its ongoing commitment to ensure the availability of safe and effective medicines in Nigeria and to protect public health.
Product Name: All brands of Multi-Dose Artemether/Lumefantrine dry powder for oral suspension
Consumers and healthcare providers are advised to comply with the directive and only use approved anti-malarial alternatives to prevent potential health risks.