The National Agency for Food and Drugs Administration and Control (NAFDAC), has banned the sale of Turkey-made Dex Luxury Bar Soap in the country.
The Agency also called on Nigerians to watch out for the counterfeit of Tandak injection powder made in India.
According to a statement on NAFDAC website, Dex Luxury Bar Soap does not comply with the Cosmetic Products Regulation of Nigeria. The Agency explained that the soap contains Butyphenyl Methylpropional, which is prohibited in cosmetic products. It stated that ban was due to its risk of harming the reproductive system and causing harm to the health of the unborn child. The product also causes 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,” the statement stated.
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NAFDAC noted that the product has a barcode number 8694965531 and product was manufactured in Turkey.
The agency, therefore, cautioned that though the product was not in the NAFDAC database, it advised importers, distributors, retailers, and consumers to remain vigilant. It stated that this is important to avoid the importation, distribution, sale, and use of the soap.
“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: http://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.
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NAFDAC also alerted Nigerians to the sale of counterfeit Tandak injection 1.5g powder and water for injection.
It stated that the product was discovered in Gombe State. The presence of the counterfeit product was reported to the NAFDAC by Marcson Healthcare Ltd., the marketing authorization holder.
The agency, therefore, 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.
The agency, however, pointed to how to differentiate the original product from the counterfeiter product. It 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.
NAFDAC stated that the original brand has a hologram on the primary carton. While the counterfeited brand does not have it. Also a mobile authentication service label is present in the original product. But it is photocopied/scanned in the fake product.
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“The original product has a green cap on the vial, while the cap on the vial of the fake one is white.
The agency also noted that while the leaflet insert is present in the original product, the fake product has none.
It stated therefore, that, “NAFDAC has directed all Zonal Directors and State Coordinators to carry out surveillance on the product. It ordered them to 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,” NAFDAC stated.
