Due to stability concerns, 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.
This decision affects all locally manufactured and imported products, and NAFDAC will no longer accept new applications, renewals, or variations for this product.
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The announcement was made in a public alert No. 01/2025, released on the agency’s website Thursday.
NAFDAC explained that the decision was made due to the instability of the reconstituted formulations, which can lead to a loss of efficacy over time.
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According to the agency, stability studies have shown that the reconstituted oral suspension becomes unstable after mixing, leading to a loss of efficacy over time.
It said this can result in worsening health conditions, increased risks of complications, treatment delays, or even death.
Implementation
NAFDAC had directed all zonal directors and state coordinators to carry out surveillance activities and remove all locally manufactured and imported products from circulation.
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The agency also advised importers, distributors, retailers, healthcare professionals, and caregivers to cease the importation, distribution, and sale of the product immediately.
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It said healthcare professionals and consumers had been urged to report any suspected sale of these products and any substandard or falsified medicines to the nearest NAFDAC office.
The agency said the public could also report adverse events or side effects through its 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 Organisation’s (WHO) Global Surveillance and Monitoring System (GSMS).
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