NAFDAC Withdraws Registration of Artemether/Lumefantrine Oral Suspension over Stability Concerns
National Agency for Food and Drug Administration and Control (NAFDAC) has announced the discontinuation of the registration of Multi-Dose Anti-Malarial (Artemether/Lumefantrine) dry powder for oral suspension.
NAFDAC Withdraws Registration of Artemether/Lumefantrine Oral Suspension over Stability Concerns
The decision follows stability concerns, as studies have shown that the reconstituted formulations lose efficacy over time.
The announcement was made in a public alert No. 01/2025, released on the agency’s website.
NAFDAC confirmed that the suspension applies to all locally manufactured and imported Multi-Dose Artemether/Lumefantrine dry powder for oral use.
Consequently, the agency will no longer accept new applications, renewals, or variations for any local or imported Multi-Dose Artemether/Lumefantrine dry powder for oral suspension.
According to NAFDAC, stability studies revealed that reconstituted Artemether/Lumefantrine oral suspension becomes unstable after mixing, leading to a loss of efficacy.
“This loss can have severe health consequences, including treatment failure, increased risk of complications, and, in extreme cases, death,” the agency stated.
All NAFDAC zonal directors and state coordinators have been instructed to conduct surveillance and remove all affected products from circulation.
The agency has also directed importers, distributors, retailers, healthcare professionals, and caregivers to immediately halt the importation, distribution, sale, and use of these medications.
NAFDAC has urged healthcare professionals and consumers to report any suspected sale of these products or related substandard medicines to the nearest NAFDAC office or via the agency’s toll-free number: 0800-162-3322. Reports can also be submitted via email at sf.alert@nafdac.gov.ng.
Additionally, individuals are encouraged to report adverse reactions through the Med-Safety mobile app, available on Android and iOS, or via email at pharmacovigilance@nafdac.gov.ng.
NAFDAC confirmed that this notification would be uploaded to the World Health Organization (WHO) Global Surveillance and Monitoring System (GSMS) as part of its regulatory measures.
