NAFDAC directs withdrawal of multi-dose malaria oral suspension still in circulation
The National Agency for Food and Drug Administration and Control (NAFDAC) has directed the immediate withdrawal of multi-dose Artemether/Lumefantrine dry powder for oral suspension still in circulation across the country.
The National Agency for Food and Drug Administration and Control (NAFDAC) has directed the immediate withdrawal of multi-dose Artemether/Lumefantrine dry powder for oral suspension still in circulation across the country.
The agency reiterated that the multi-dose malaria oral suspension is no longer approved for registration, importation, or use in Nigeria.
The alert was issued in a public notice on the agency’s website and was previously announced in Public Alert No. 01/2025 on February 27, 2025.
This comes as Surveillance reports indicate that these oral suspension products are still in circulation and being dispensed to patients.
The agency directed all manufacturers and importers of Multi-Dose Artemether/Lumefantrine dry powder for oral suspension to switch production to dispersible tablets or single-dose sachets.
The agency said the instability of reconstituted anti-malarial suspensions reduces the effectiveness of the medicine, increasing the risk of treatment failure and poor health outcomes for patients.
Following its continuous circulation, NAFDAC has therefore instructed all zonal directors and state coordinators to carry out surveillance and remove all affected products from markets within their jurisdictions.
Importers, distributors, retailers and healthcare professionals are advised to immediately stop the importation, distribution, sale, and use of all Multi-Dose Anti-Malarial Oral Suspension products.
This latest directive comes amid a series of recent safety alerts issued by NAFDAC to curb the circulation of unsafe and substandard medical products in Nigeria.
Similarly, the agency warned about the circulation of falsified Dostinex 0.5mg tablets in Nigeria, noting that while the genuine product is registered, it has not yet been officially imported into the country.
The identified fake batches, GG3470, LG8659, and GG2440, have no NAFDAC registration and may pose serious health risks.
