The National Agency for Food and Drugs Administration and Control has alerted Nigerians to the sale of counterfeit Tandak injection 1.5g powder and water for injection.
NAFDAC said the product is manufactured by Intracin Pharmaceuticals in Gujarat, India.
NAFDAC said the product was discovered in Gombe state, and was reported to the agency by Marcson Healthcare Ltd., the marketing authorisation holder.
It said, “Tandak® injection of 1.5g powder is a co-formulation of Ceftriaxone 1000mg and Sulbactam 500mg. It is prescribed for use in the treatment of various types of bacterial infections.
“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 agency warned that the illegal marketing of counterfeit medicines poses a risk to the health of people, since by not complying with the regulatory provisions, the safety, quality, and efficacy of the products are not guaranteed.
Differentiating the original product from the counterfeiter product, the agency said the batch number of the original product is BN: 23P24, while the counterfeited has 22P21 as its batch number.
The original was manufactured in August 2023, and will expire in July 2025; while the fake was manufactured on May 2022, and would expire in August 2026.
It said the original brand has a hologram on the primary carton but the counterfeited brand does not have it. A mobile authentication service label is present in the original product but it is photocopied/scanned in the fake product.
The original product has a green cap on the vial while the cap on the vial of the fake one is white.
It also notified that while the leaflet insert is present in the original product, the fake product has none.
NAFDAC noted that the logo of the exporter for the original product is Prime Pharmaceutical Pvt Ltd, but the logo of the exporter of the fake product is wrong and inconsistent
“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 the 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: [email protected]
“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 [email protected],” it said.
