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NAFDAC recalls Benylin children cough syrup over toxicity concerns
The National Agency for Food and Drugs Administration and Control (NAFDAC) has recalled one of the Benylin Paediatric Syrups, manufactured by Johnson & Johnson.
NAFDAC disclosed this on its website on Wednesday, stating that 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.
“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,” NAFDAC explained.
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.
The product’s details revealed that Johnson & Johnson manufactured it in Cape Town, South Africa.
With batch number 329304, the product was manufactured in May 2021, and it is to expire in April 2024.
As a result, NAFDAC has urged importers, distributors, retailers, and consumers to exercise caution and vigilance within the supply chain to avoid the importation, distribution, sale, and use of substandard (contaminated) regulated products.
“All medical products must be obtained from authorized/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 nearest NAFDAC office. If you witness any adverse reaction or event after the use of this product in any children, you are advised to direct such patients for immediate medical attention from a qualified healthcare professional,” the agency cautioned.
Meanwhile, NAFDAC has urged healthcare professionals and consumers to report any suspicions of substandard and falsified medicines to the nearest NAFDAC office.
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 its website.
Also, the agency has directed the Marketing Authorization 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).
