Sequel to the reported circulation of counterfeit Combiart Dispersible Tablet 20/120mg in the country, the National Agency for Food and Drugs Administration and Control (NAFDAC) has informed the public about potential health risks.
Team@orientactualmags.com learned that NAFDAC disclosed this via a post on its X.com on Thursday while noting that the anti-malaria drug in question is manufactured by Strides Arcolab Limited, 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 submitted.
The agency warned that contefeit drugs pose significant risks to health as they do not meet regulatory standards, and as such their safety, quality, and efficacy cannot be assured and they 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 A11-0299 adding that the manufacturing dates on the product are June 2023 and February 2023, while the expiry dates are 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 has also 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 have also been 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 submitted while asking healthcare professionals and consumers 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.
NAFDAC added that 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
The agency also noted that the public health alert will be uploaded to the World Health Organization Global Surveillance and Monitoring System–Team@orientactualmags.com Do you have any information you wish to share with us? Do you want us to cover your event or programme? Kindly send SMS to 08059100286, 09094171980 or get in touch via orientactualmag@gmail.com. Thank you
