NAFDAC recalls ‘toxic’ drug expiring this month after selling for at least 2 years in Nigeria

THE National Agency for Food and Drugs Administration and Control has recalled Benylin Paediatrics Syrup manufactured by Johnson & Johnson following recent toxicity findings in the laboratory on the product.

Benylin Paediatric syrup is commonly used to relieve cough and congestive symptoms in children aged two to 12. It also treats hay fever and other allergic conditions in the same age group.

In a statement disclosed on its website on Wednesday, April 10, NAFDAC said laboratory analysis of the product showed that it contained an alarming level of diethylene glycol, which causes acute oral toxicity in laboratory animals.

“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 two to 12 years.

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“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,” it noted.

The agency revealed that the drug, manufactured by Johnson & Johnson in Cape Town, South Africa, and with batch number 329304 was produced in May 2021 and would expire this month (April 2024).

The ICIR reports that given this analysis, the product could have been on shelves nationwide for at least two years.

The NAFDAC said it had contacted the marketing authorisation holder (Johnson and Johnson company, West Africa) to initiate the batch recall, adding that the notice would also be uploaded to the WHO Global Surveillance and Monitoring System.




     

     

    It also urged importers, distributors, retailers, and consumers to exercise caution and vigilance throughout the supply chain to prevent the importation, distribution, sale, and use of substandard (contaminated) regulated products.

    Screenshot of the table by NAFDAC showing the drug's details
    Screenshot of the table by NAFDAC showing the drug’s details

    “Anyone in possession of the above-mentioned product is advised to immediately discontinue the sale or use and submit stock to the nearest NAFDAC office. If you witness any adverse reaction/event after the use of this product in any children, you are advised to direct such patients to immediate medical attention from a qualified healthcare professional.

    “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:[email protected]

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    “Similarly, healthcare professionals and patients are 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 [email protected],” it added.

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    Usman Mustapha is a solution journalist with International Centre for Investigative Reporting. You can easily reach him via: [email protected]. He tweets @UsmanMustapha_M

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