The National Agency for Food and Drug Administration and Control (NAFDAC) has issued a warning about the circulation of counterfeit Combiart Dispersible Tablet 20/120mg in the country.
In a post on its X handle on Thursday, the agency announced it has directed its offices nationwide to commence an immediate mop-up of the fake malaria drug, reportedly produced by Strides Arcolab Limited 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 licence 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 cautioned that counterfeit or falsified medicines pose significant health risks as they fail to meet regulatory standards, compromising their safety, quality, and efficacy.
The agency explained that such medicines often do not effectively treat diseases or conditions, potentially resulting in severe health outcomes, including death.
It identified the counterfeit product as batch number 7225119, with a NAFDAC registration number A11-0299. The manufacturing dates are listed as February 2023 and June 2023, with expiry dates of June 2026 and May 2026, respectively.
The stated manufacturer is Strides Arcolab Limited, located at 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 caregivers 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. The products’ authenticity and physical condition should be carefully checked.
“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 on pharmacovigilance@nafdac.gov.ng,” it said.
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