NAFDAC Issues Public Alert on Substandard and Falsified ARTEMETRIN DS Tablets in Nigeria
NAFDAC Issues Public Alert on Substandard and Falsified ARTEMETRIN DS Tablets in Nigeria
The National Agency for Food and Drugs Administration and Control (NAFDAC) has raised alarm over the circulation of falsified and substandard batches of ARTEMETRIN DS (Artemether 80mg + Lumefantrine 480mg) tablets in Nigeria. The medicine, which is widely used for the treatment of malaria, has been found to contain dangerously low levels of its active ingredients, posing a serious threat to public health.
Details of the Affected Product
Product Name: ARTEMETRIN DS (Artemether 80mg + Lumefantrine 480mg)
Dosage Form: Tablets
Labelled Manufacturer: A.C. DRUGS Ltd, Plot C5/C6 Old Airport Road, Emene, Enugu State, Nigeria
Batch No.: All batches
Packaging Language: English/French
Stated NAFDAC Reg. No.: A4-3164 (Confirmed to be false)
Country Identified: Nigeria
Laboratory Findings
Initial screening using thin-layer chromatography (TLC) revealed irregularities. Further analysis conducted in a WHO-prequalified laboratory using high-performance liquid chromatography (HPLC) confirmed that the tablets contained only 59.2% Artemether and 71.2% Lumefantrine. This falls well below the acceptable 90–110% range for active pharmaceutical ingredients (APIs).
Why This Is a Serious Concern
Artemether/Lumefantrine combinations, such as ARTEMETRIN DS, are first-line treatments for acute, uncomplicated malaria in adults and children. Using medicines with insufficient API levels can lead to:
Treatment failure, leaving malaria untreated.
Increased risk of severe illness or death in vulnerable patients, including children and pregnant women.
Acceleration of antimicrobial resistance, making malaria harder and more expensive to treat in the future.
NAFDAC’s Position
NAFDAC has confirmed that the product does not exist in its official registered database and that the NAFDAC registration number printed on the packaging is falsified. The agency has warned both healthcare providers and the general public to remain vigilant and avoid dispensing or consuming this medicine.
Practical Steps for Individuals
To stay safe from falsified or substandard medicines, Me and You Pharma recommends that patients and healthcare providers take the following actions:
Buy from licensed pharmacies only – Avoid purchasing medicines from open markets, buses, or unverified online sources.
Verify NAFDAC registration numbers – Use the NAFDAC verification platform to confirm the authenticity of the numbers.
Check packaging details carefully – Watch out for inconsistencies in spelling, print quality, or batch numbers.
Report suspicious products – Immediately notify NAFDAC if you encounter any medicine that looks falsified or ineffective.
Consult a pharmacist – Before starting any malaria treatment, confirm with a qualified pharmacist that the product is genuine.
Me and You Pharma’s Commitment
At Me and You Pharma, we are committed to safeguarding the health of Nigerians by providing timely health alerts, pharmacist-reviewed resources, and practical advice for medication safety. Our mission is to ensure patients can access safe, effective, and reliable medicines when they need them most.
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