PUBLIC ALERT NO. 09/2026: REMINDER OF NAFDAC’S REGULATORY DIRECTIVE ON THE DISCONTINUED REGISTRATION OF MULTI-DOSE ARTEMETHER/LUMEFANTRINE DRY POWDER FOR ORAL SUSPENSION.

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​Link: https://bit.ly/4cOVNLB

​NAFDAC is reminding the public of the Regulatory Directive issued last year regarding the discontinued registration of multi-dose anti-malarial (Artemether/Lumefantrine) dry powder for oral suspension. This is due to the instability of the reconstituted formulations, which results in a loss of efficacy of the suspension.

​See Public Alert No. 01/2025, published on the NAFDAC website on 27 February 2025: bit.ly/4h4ylsi

​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, or variation applications for any local or imported multi-dose Artemether/Lumefantrine dry powder for oral suspension. Manufacturers are required to produce either dispersible tablets or powder/granules 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 result in death.

​Product Details

• ​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.

​Healthcare professionals and consumers are advised to report any suspicion of the sale of these products, substandard or falsified medicines, or medical devices to the nearest NAFDAC office. You may also call 0800-162-3322 or send an email to sf.alert@nafdac.gov.ng.