The National Agency for Food and Drug Administration and Control (NAFDAC) has alerted Nigerians to the circulation of counterfeit Combiart Dispersible Tablet (20/120mg) in the country.
The agency issued the warning through its X handle on Thursday, that the fake product is falsely labelled as being manufactured by Strides Arcolab Limited, an India-based pharmaceutical company.
“This counterfeit product was discovered during surveillance activities in the FCT and Rivers State by officers of the Post Marketing Surveillance Directorate of NAFDAC,” the agency stated.
According to NAFDAC, laboratory analysis revealed that the counterfeit tablets contain zero active pharmaceutical ingredients (APIs), It also bore two different date markings, further confirming its counterfeit nature.
Expired licence and false registration number
- NAFDAC’s database of registered products confirmed that the licence for Combiart has expired. Additionally, the NAFDAC Registration Number displayed on the product is incorrect.
- The product has batch number 7225119 and a NAFDAC registration number A11-0299 and is not associated with authentic medication.
Risks of counterfeit medicines
NAFDAC highlighted that counterfeit medicines pose significant health risks as they fail to meet regulatory safety and efficacy standards. “The use of such products may lead to treatment failure, serious health consequences, or even death.”
“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,” the agency stated.
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 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 authorized/licensed suppliers. The authenticity and physical condition of the products should be carefully checked,” NAFDAC advised.
“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.
NAFDAC also urged healthcare professionals and patients to report adverse events or side effects related to the use of the product to the nearest NAFDAC office or through the E-reporting platforms available on the NAFDAC website, www.nafdac.gov.ng.
The public can also submit their complaints through the Med safety application, which is available for download on Android and iOS stores or simply send an email to pharmacovigilance@nafdac.gov.ng.
