In a Public Alert No. 013/2024 -Alert on ‘Recall of Benylin Paediatrics Syrup in Nigeria,’ NAFDAC revealed 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.
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.
In a Public Alert No. 013/2024 -Alert on ‘Recall of Benylin Paediatrics Syrup in Nigeria,’ NAFDAC revealed 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.
According to the agency, Benylin Paediatric syrup is indicated for the relief of cough and its congestive symptoms and the treatment of hay fever and other allergic conditions in children ages two to 12.
On the risk associated with diethylene glycol, the agency explained that it 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 said.
As a product recall is an important method of managing risks in response to product safety events and emergencies, NAFDAC gave the details of the product as the product manufactured by Johnson & Johnson in Cape Town, South Africa.
With batch number 329304, the product was manufactured in May 2021, and it is to expire this month, April 2024.
It said, “NAFDAC implores 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 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/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.
“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.”
According to the public alert, the agency said it had directed the Marketing Authorization Holder (Johnson and Johnson Company West Africa) to initiate the recall of the batch, adding that the notice will also be uploaded to the WHO (World Health Organisation) Global Surveillance and Monitoring System (GSMS).”
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