The National Agency for Food and Drugs Administration and Control (NAFDAC) is reminding the public of the Regulatory Directive issued last year on the discontinued registration of Multi-Dose Anti-Malarial (Artemether/Lumefantrine) dry powder for Oral Suspension due to the instability of the reconstituted formulations, which results in the loss of efficacy of the suspension.
See Public Alert No. 01/2025 published on the NAFDAC website on the 27th of February 2025.
This Regulatory Directive applies to all locally manufactured and imported Multi-Dose Artemether/Lumefantrine dry powder for oral use.
NAFDAC no longer accepts New, Renewal, and Variation applications for all local and imported Multi-Dose Artemether/Lumefantrine dry powder for oral suspension.
The manufacturers will need to produce either dispersible tablets or powder/granule packed in sachets for single doses.
Risk Statement
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.
Product details
The details of the product are as follows.
Product Brand Name: All brands of Multi-Dose Artemether/Lumefantrine dry powder for oral suspension.
Product Manufacturer: All manufacturers and Importers of Multi-Dose Anti-Malarial (Artemether/ Lumefantrine dry powder Oral Suspension.
Surveillance reports from various states have indicated that the above products are still in circulation and being dispensed to patients.
All NAFDAC zonal directors and state coordinators have been directed to carry out surveillance activities and mop up all locally manufactured and imported Multi-Dose Artemether/Lumefantrine dry powder for oral suspension products within the zones and states.
Importers, distributors, retailers, healthcare professionals, and caregivers are hereby advised to immediately stop the importation, distribution, sale, and use of all Multi-Dose Anti-Malarial Oral Suspension products.
Healthcare professionals and consumers are advised to report any suspicion of sale of these products, substandard and falsified medicines, or medical devices to the nearest NAFDAC office, NAFDAC on 0800-162-3322, or via email: sf.alert@nafdac.gov.ng
Similarly, healthcare professionals and patients are also encouraged to report adverse events or side effects related to the use of medicinal products or devices to the nearest NAFDAC office, or through the use of the E-reporting platforms available on the NAFDAC website www.nafdac.gov.ng, or via the Med- safety application available for download on Android and IOS stores, or via e-mail on pharmacovigilance@nafdac.gov.ng
For complaints, you can call the Reforms Unit on the following lines: 09097630506, 09097630507, or email: reforms@nafdac.gov.ng
Furthermore, note that this notice will be uploaded to the WHO Global Surveillance and Monitoring System (GSMS).
NAFDAC………. Customer-focused, Agency-minded!!!
