The National Agency for Food and Drug Administration and Control (NAFDAC) has officially withdrawn the registration of Multi-Dose Anti-Malarial (Artemether/Lumefantrine) dry powder for oral suspension due to critical stability concerns.
In a statement released as Public Alert No. 01/2025 on the agency’s website, NAFDAC revealed that studies had shown a significant loss of efficacy in reconstituted formulations over time.
The decision applies to all locally manufactured and imported Multi-Dose Artemether/Lumefantrine dry powder for oral suspension, with the agency confirming that no new applications, renewals, or variations for these products will be accepted.
According to NAFDAC, stability testing demonstrated that the reconstituted suspension becomes unstable after mixing, leading to a deterioration in potency. This could result in treatment failure, increased risk of malaria complications, and, in severe cases, fatal outcomes.
NAFDAC Director-General, Professor Mojisola Adeyeye, stressed the urgency of the withdrawal, stating that all zonal directors and state coordinators have been instructed to conduct nationwide surveillance and remove affected products from circulation immediately.
The agency has also directed all importers, distributors, retailers, healthcare providers, and caregivers to cease the importation, sale, and use of these medications with immediate effect.
Consumers and healthcare professionals are urged to report any ongoing sales of these banned products or any suspected substandard medications to NAFDAC through its toll-free number: 0800-162-3322 or via email at sf.alert@nafdac.gov.ng.
Additionally, adverse reactions can be reported using the Med-Safety mobile app available on Android and iOS or by emailing pharmacovigilance@nafdac.gov.ng.
As part of its global regulatory responsibility, NAFDAC has confirmed that the notification of this withdrawal will be forwarded to the World Health Organization (WHO) Global Surveillance and Monitoring System (GSMS) to ensure international awareness and cooperation.
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