- NAFDAC discontinues registration of the Multi-Dose Anti-Malarial dry powder for oral suspension due to instability concerns.
- The decision affects both locally manufactured and imported products, with no new applications, renewals, or variations accepted.
- Importers, distributors, and healthcare professionals are instructed to cease distribution immediately and report any adverse events.
The National Agency for Food and Drug Administration and Control (NAFDAC) has withdrawn the registration of the Multi-Dose Anti-Malarial (Artemether/Lumefantrine) dry powder for oral suspension.
EKO HOT BLOG reports that this decision, detailed in Public Alert No. 01/2025 released on the agency’s website on Thursday, comes after stability studies revealed that once reconstituted, the formulation becomes unstable, potentially leading to a loss of efficacy over time.
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The suspension, which covers all locally manufactured and imported versions of the product, will no longer accept new applications, renewals, or variations. NAFDAC warned that the instability could worsen health conditions, increase the risk of complications, delay treatment, or even result in death.
In response, the agency has instructed all zonal directors and state coordinators to conduct surveillance and remove any of these products from circulation immediately. Importers, distributors, retailers, healthcare professionals, and caregivers have been advised to cease the importation, distribution, and sale of the product.
Healthcare providers and consumers are urged to report any suspected sales, as well as any substandard or falsified medicines, to their nearest NAFDAC office.
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Additionally, adverse events or side effects can be reported via the agency’s E-reporting platforms or through the Med-safety application available on Android and iOS.
NAFDAC also mentioned that this alert will be shared with the World Health Organization’s Global Surveillance and Monitoring System (GSMS).
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