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Health Alert: NAFDAC announces recall of Benylin Paediatrics Syrup, ban on sale of soap brand in Nigeria

Photo Collage Credit: Channels TV

*The National Agency for Food and Drugs Administration and Control discloses the laboratory analysis conducted on the product showed that it contains an unacceptable high level of Diethylene glycol and was found to cause acute oral toxicity in laboratory animals

Isola Moses | ConsumerConnect

As part of its “Customer- focused, Agency-minded” mandate to promote and protect the well-being of Nigerians, the National Agency for Food and Drugs Administration and Control (NAFDAC) has alerted Nigerian consumers to recall of one lot of Benylin Paediatrics Syrup because  of the recent toxicity findings on the product.

ConsumerConnect reports the affected syrup is being manufactured by Johnson & Johnson (Pvt), based in Cape Town, South Africa.

The health sector regulatory agency, in an advisory released Wednesday, April 10, 2024, disclosed the laboratory analysis conducted on the product showed that it contains an unacceptable high level of Diethylene glycol and was found to cause acute oral toxicity in laboratory animals.

NAFDAC stated: “Benylin Paediatric syrup is indicated for the relief of cough and its congestive symptoms and for the treatment of hay fever and other allergic conditions in children aged 2 to 12 years.”

Risk and what product consumers should do

In regard to the risk associated with the recalled syrup, the agency explained Diethylene glycol is “toxic to humans when consumed and can prove fatal.

“Toxic effects can include abdominal pain, vomiting, diarrhoea, inability to pass urine, headache, altered mental state, and acute kidney injury which may lead to death.”

The health regulatory agency, therefore, implored importers, distributors, retailers and consumers to exercise caution and vigilance within the supply chain to avoid the importation, distribution, sale and use of the substandard (contaminated) regulated products.

“All medical products must be obtained from authorised/licensed suppliers.

The products’ authenticity and physical condition should be carefully checked.

“Anyone in possession of the above-mentioned product is advised to immediately discontinue sale or use and submit stock to the nea​rest NAFDAC office,” it said in the advisory.

The agency equally advised consumers who witness any adverse reaction/event after the use of this product in any children to direct such patients for immediate medical attention from a qualified healthcare professional.

NAFDAC further stated: “Healthcare professionals and consumers are advised to report any suspicion of substandard and falsified medicines 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 the medicinal product 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

The Agency noted it had directed the Marketing Authorisation Holder (Johnson and Johnson company West Africa) to initiate the recall of the batch and the notice will also be uploaded to the WHO Global Surveillance and Monitoring System (GSMS).

 Ban on sale of Dex Luxury Bar Soap over Butyphenyl Methylpropional content

In a related development, the health regulatory agency recently alerted Nigerians to the ban on sale of Dex Luxury Bar Soap (No 6 Mystic Flower) by the European Union (EU).

NAFDAC also announced that the “product does not comply with the Cosmetic Products Regulation as it is said to contain Butyphenyl Methylpropional (BMHCA), 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.”

It revealed a ban on the marketing of the product had been placed by some regulatory and public authorities, in the EU.

On the affected product details, Nigeria’s health sector regulatory agency the cosmetics product, manufactured by DEX, in Turkey, affected Model 11.11.22 with Barcode  8694965531.

Product not registered in Nigeria, says NAFDAC

The agency explained although the product category is not in the NAFDAC database, importers, distributors, retailers, and consumers are advised to exercise caution and vigilance within the supply chain to avoid the importation, distribution, sale, and use of the above-mentioned product.

It averred: “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.”

NAFDAC said 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.

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