NAFDAC is notifying healthcare providers, importers, distributors, retailers, Patent and Proprietary Medicine Vendors (PPMVs), and the general public of the seizure of a suspected substandard and falsified (SF) antimalarial medicine, Artemether/Lumefantrine 80mg/480mg, purportedly manufactured by Bandaram Pharma Packleh Ltd (BPPL), India.

The product was intercepted by NAFDAC officials during routine Post-Market Surveillance activities at the Coordinated Wholesale Centre (CWC), Kano State. NAFDAC verification confirmed that the NAFDAC Registration Number 02-3457 displayed on the product is fake and does not exist in the Agency’s registration database.

The product label does not indicate the MAH information.

Given that Artemether/Lumefantrine is used in the treatment of malaria, the circulation and use of falsified products may result in treatment failure, worsening of disease, development of drug resistance, and other serious public health consequences. The product has therefore been classified as a Falsified (F) Medical Product.

Healthcare professionals and members of the public are advised to:
•Exercise caution and avoid the purchase, sale, supply, or use of the affected product.
•Obtain medicines only from authorised and licensed suppliers.
•Carefully check the authenticity of medicines before purchase and use.
•Report any suspected sale, distribution, or use  of the product to the nearest NAFDAC office.

@nafdacAgency