The National Agency for Food and Drug Administration and Control (NAFDAC) has alerted the public to the circulation of counterfeit Combiart Dispersible Tablet 20/120 mg in the country.
In a statement on its X handle on Thursday, the NAFDAC said it had alerted its offices nationwide to begin the immediate mop-up of the fake malaria drug manufactured by Strides Arcolab Limited, based in India.
“This product was discovered in the FCT and Rivers State during surveillance activities conducted by officers of the Post Marketing Surveillance Directorate of NAFDAC.
“The laboratory report of the analysis carried out on the product revealed that it contained zero active pharmaceutical ingredients. The product was also observed to have two different date markings.
“The NAFDAC database of registered products has confirmed that the product license has expired and the NAFDAC Registration Number on it is wrong and not for the product.
“The Artemether and Lumefantrine combination belongs to a group of medicines known as antimalarials. It treats malaria, a red blood cell infection transmitted by the bite of a mosquito. However, this medicine is not used to treat severe or complicated malaria,” it said.
NAFDAC warned that counterfeit or falsified drugs risk people’s health because they do not meet regulatory criteria, implying that the items’ safety, quality, and efficacy are not guaranteed.
It further stated that the use of counterfeit drugs frequently fails to successfully cure diseases or conditions, resulting in catastrophic health repercussions, including death.
The agency stated that the product batch number is 7225119, and the NAFDAC registration number is A11-0299.
It stated that the product’s manufacturing dates are June 2023 and February 2023.
The expiration dates are May and June 2026. Strides Arcolab Limited’s address is 36/7, Suragajakkanahalli, Indlavadi Cross, Anekal Taluk, Bangalore, 562 106, India.
“All NAFDAC zonal directors and state coordinators have been directed to carry out surveillance and mop up the counterfeit products within the zones and states.
Importers, distributors, retailers, healthcare professionals, and carers are hereby advised to exercise caution and vigilance within the supply chain to avoid the importation, distribution, sale, and use of counterfeit products. All medical products must be obtained from authorised/licensed suppliers, and their authenticity and physical condition should be carefully examined.
“Healthcare professionals and consumers are advised to report any suspicion of the sale of substandard and falsified medicines or medical devices to the nearest NAFDAC office, NAFDAC, on 0800-162-3322 or via email: sf.alert@nafdac.gov.ng.
“Similarly, healthcare professionals and patients are also encouraged to report adverse events or side effects related to the use of medicinal products or devices to the nearest NAFDAC office, or through the use of the e-reporting platforms available on the NAFDAC website www.nafdac.gov.ng, or via the Med-Safety application available for download on Android and iOS stores, or via e-mail at pharmacovigilance@nafdac.gov.ng,” it said.
