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.
What the agency said
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.
- Regulatory Directive applies to all locally manufactured and imported Multi-Dose Artemether/Lumefantrine as it no longer accepts new, renewal, or variation applications for these oral suspension products.
- “Stability studies have demonstrated that reconstituted anti-malarial suspensions are unstable, resulting in a loss of efficacy. When a medication loses its efficacy, it becomes less effective, which can have serious health consequences. This may lead to a worsening of the treated condition, an increased risk of complications, delays in treatment, and, in severe cases, could even result in death,” NAFDAC stated.
- Product brand name: All brands of Multi-Dose Artemether/Lumefantrine dry powder for oral suspension including Bellartem, Lokmal, HAVAX, PALUDEX, WINART, BIOLUMEFAR, FANETHA, Artemelum, and Cikatem.
More insights
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.
- Consumers and healthcare professionals are urged to report any suspected sale of substandard or falsified anti-malarial products, or adverse effects from their use, to the nearest NAFDAC office, via the Med-safety mobile application, e-reporting platforms on www.nafdac.gov.ng or email: pharmacovigilance@nafdac.gov.ng
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.
What you should know
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.
- In a recent public notice, the agency announced a precautionary recall of certain Aptamil and Cow & Gate infant and follow-on milk formulas over possible contamination with cereulide, a toxin produced by the bacterium Bacillus cereus, which can cause nausea, severe vomiting, and other foodborne illnesses, particularly in infants.
- NAFDAC had also flagged a suspected revalidated SMA Gold infant formula discovered in Kaduna State after altered expiry dates were linked to illness in a four-month-old infant.
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.
