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The National Agency for Food and Drugs Administration and Control has raised an alert over the circulation of counterfeit Combiart Dispersible Tablet 20/120mg in Nigeria.
NAFDAC disclosed this via a post on its X handle on Thursday.
According to the agency, the product is 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 confirmed that the product licence has expired, and the NAFDAC registration number on it is incorrect and does not belong to 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 mosquito bites. However, this medicine is not used to treat severe or complicated malaria,” NAFDAC stated.
The agency warned that counterfeit medicines pose significant risks to health as they do not meet regulatory standards, meaning their safety, quality, and efficacy cannot be assured.
It added that counterfeit medicines often fail to effectively treat conditions, leading to severe health consequences, including death.
NAFDAC identified the product’s batch number as 7225119, with a NAFDAC registration number of A11-0299. It noted that the manufacturing dates on the product were June 2023 and February 2023, while the expiry dates were May 2026 and June 2026.
The manufacturer’s name and address were listed as:
Strides Arcolab Limited, 36/7, Suragajakkanahalli, Indlavadi Cross, Anekal Taluk, Bangalore (562 106), India.
The agency directed all its zonal directors and state coordinators to conduct surveillance and remove the counterfeit products from circulation. Importers, distributors, retailers, healthcare professionals, and caregivers were urged 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. The authenticity and physical condition of the products should be carefully checked,” NAFDAC advised.
Healthcare professionals and consumers were also urged to report any suspicion of substandard or falsified medicines or medical devices to the nearest NAFDAC office. Reports can also be made via the NAFDAC hotline at 0800-162-3322 or by email at sf.alert@nafdac.gov.ng.
Similarly, adverse events or side effects related to the use of medicines or devices should be reported through the NAFDAC e-reporting platform on its website, the Med-Safety app (available on Android and iOS), or via email at pharmacovigilance@nafdac.gov.ng.
NAFDAC noted that the alert will also be uploaded to the World Health Organisation Global Surveillance and Monitoring System.
