NAFDAC has issued a warning to Nigerians regarding a counterfeit product, Tandak® injection, found in Gombe state. The agency was alerted to this by Marcson Healthcare Ltd., the Marketing Authorisation Holder.
The counterfeit product, manufactured by Intracin Pharmaceuticals in Gujarat, India, is a co-formulation of Ceftriaxone 1000mg and Sulbactam 500mg used to treat bacterial infections.
NAFDAC advises the public to be cautious when purchasing pharmaceutical products and to report any suspicious products to the appropriate authorities.
“It fights against the microorganisms by preventing their growth and further spread of the infection. Ceftriaxone+Sulbactam 1000mg/500mg Injection should only be administered under the supervision of a healthcare professional.”
The regulatory agency cautioned about the dangers of illegally marketing counterfeit medicines, emphasizing the risks to public health due to non-compliance with safety standards. Unauthorized products lack guaranteed safety, quality, and effectiveness, posing a threat to consumers.
Providing distinguishing features, NAFDAC highlighted key differences between the original and counterfeit products. The original batch number, BN: 23P24, contrasts with the fake product’s batch number, 22P21. Manufacturing and expiration dates revealed further disparities, with the original made in August 2023 and expiring in July 2025, while the fake was produced in May 2022 and would expire in August 2026.
Among other discrepancies, NAFDAC noted that the original brand carries a hologram on the primary carton, which is absent in the counterfeit version. Authentication features like a mobile service label are replicated in the fake product, and packaging details such as the cap color on the vial differ between the authentic (green) and fake (white) versions.
Moreover, the presence of a leaflet insert in the original product distinguishes it from the counterfeit, which lacks this component. The exporter’s logo further sets the authentic product apart, with the original displaying the logo of Prime Pharmaceutical Pvt Ltd, while the counterfeit features an incorrect and inconsistent exporter logo.
In essence, consumers are advised to be vigilant and verify product authenticity to ensure they receive genuine and safe medications.
“NAFDAC has directed all zonal directors and state coordinators 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 authorized/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 inserted.
Wakadaily reported that , NAFDAC’s mandate is to safeguard and enhance public health by implementing a robust regulatory framework to ensure that food, pharmaceuticals, and other regulated items meet stringent quality standards during their production, exportation, importation, marketing, distribution, sales, and consumption.
