The National Agency for Food and Drugs Administration and Control has banned the sale of Turkey-made Dex Luxury Bar Soap.
It also called on Nigerians to watch out for the counterfeit of Tandak injection powder made in India.
NAFDAC, on its website, said Dex Luxury Bar Soap does not comply with the Cosmetic Products Regulation, explaining that it contains Butyphenyl Methylpropional, which is prohibited in cosmetic products due to its risk of harming the reproductive system, causing harm to the health of the unborn child and may cause skin sensitisation.
“As a result, a ban on the marketing of the product has been placed by some regulatory and public authorities in the EU,” NAFDAC stated on its website.
With barcode number 8694965531, NAFDAC noted that the product is manufactured in Turkey
It said although the product was not in the NAFDAC database, importers, distributors, retailers, and consumers were advised to exercise caution and vigilance within the supply chain to avoid the importation, distribution, sale, and use of the product.
“The product’s authenticity and physical condition should be carefully checked. Members of the public in possession of the product should discontinue the sale or use and submit stock to the nearest NAFDAC office.
“Healthcare professionals and consumers are advised to report any suspicion of adverse reactions, or substandard and falsified regulated products to the nearest NAFDAC office 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 the products 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.
The agency also alerted Nigerians to the sale of counterfeit Tandak injection 1.5g powder and water for injection.
It said the product was discovered in Gombe State and was reported to the agency by Marcson Healthcare Ltd., the marketing authorisation holder.
NAFDAC noted that the product is manufactured by Intracin Pharmaceuticals in Gujarat, India.
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,” NAFDAC wrote on its official X account.
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 in May 2022, and will 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 noted that while the leaflet insert is present in the original product, the fake product has none.
NAFDAC has directed all zonal directors and state coordinators to carry out surveillance and mop up the counterfeit products within the zones and states.
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“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.
