The National Agency for Food and Drug Administration and Control (NAFDAC) has alerted the public, including healthcare providers, importers, distributors, retailers, and Patent and Proprietary Medicine Vendors (PPMVs), to the seizure of a suspected substandard and falsified antimalarial medicine, Artemether/Lumefantrine 80 mg/480 mg.
NAFDAC stated that the medicine is purportedly manufactured by Bandaram Pharma Packleh Ltd (BPPL), India.
The agency disclosed that the product was intercepted by its officials during routine Post-Market Surveillance activities at the Coordinated Wholesale Centre (CWC) in Kano State.
According to NAFDAC, verification conducted by the agency confirmed that the NAFDAC Registration Number 02-3457 displayed on the product is fake and does not exist in the Agency’s registration database.
It added that the product label does not indicate the Marketing Authorisation Holder (MAH) information.
NAFDAC warned that, given that Artemether/Lumefantrine is used in the treatment of malaria, the circulation and use of falsified products may lead to treatment failure, worsening of the disease, development of drug resistance, and other serious public health consequences.
The agency therefore classified the product as a Falsified (F) Medical Product.
Product Photo
Front, Back, and Side view of the secondary package (Credit: NAFDAC)
NAFDAC reiterated its commitment to safeguarding public health through continuous surveillance and regulatory actions aimed at preventing the circulation of substandard and falsified medical products in Nigeria.
The regulatory agency advised healthcare professionals and members of the public to exercise caution and avoid purchasing, selling, supplying, or using the affected product.
It also urged the public to obtain medicines only from authorised and licensed suppliers and to carefully check the authenticity of medicines before purchase and use.
NAFDAC encouraged members of the public to report any suspected sale, distribution, or use of the affected product to its nearest office.
Healthcare professionals and consumers can also report suspected cases of substandard and falsified medicines or medical devices to the nearest NAFDAC office, call NAFDAC on 08001623322, or send an email to sf.alert@nafdac.gov.ng.
The agency further urged healthcare professionals and patients to report any adverse events or side effects associated with the use of medicinal products or medical devices to the nearest NAFDAC office.
Reports can also be submitted through the e-reporting platforms available on the NAFDAC website, via the Med-Safety application available for download on Android and iOS devices, or by email at pharmacovigilance@nafdac.gov.ng.
