The National Agency for Food and Drug Administration and Control (NAFDAC) has recalled Johnson & Johnson’s Benylin Paediatric Syrup.
NAFDAC, which announced this on its official website yesterday, stated that laboratory analysis of the product revealed an unacceptably excessive level of Diethylene glycol and induced acute oral toxicity in laboratory animals.
“Diethylene glycol is detrimental to humans and can be lethal. “Toxic effects can include nausea, vomiting, diarrhoea, inability to pass urine, headache, altered state of consciousness, and acute kidney injury, which may result in death,” NAFDAC explained.
Benylin Paediatric Syrup is used to relieve cough and congestive symptoms, as well as to treat hay fever and other allergy-related conditions in children between the ages of two(2) and twelve (12).
Based on its specifications, the product was manufactured in Cape Town, South Africa, by Johnson & Johnson.
Batch number 329304 indicates that the product was manufactured in May 2021 and will expire in April 2024.
NAFDAC has urged importers, distributors, retailers, and consumers to take caution and keen awareness within the supply chain to avoid importing, distributing, selling, and using more inferior (contaminated) regulated objects.
“All medical items must be bought from authorised or licenced sources. The products’ authenticity and physical condition must be properly verified.
“Anyone in possession of the aforementioned product is urged to immediately stop its sales or usage and return in stock to the nearest NAFDAC office. If you notice any adverse reaction/event in any children after using this product, you should immediately take them to a qualified healthcare professional,” the agency declared.
Furthermore, NAFDAC urged healthcare professionals and consumers to report any suspicions of substandard or counterfeit medications to the nearest NAFDAC office.
Additionally, healthcare professionals and patients were notified to report any adverse reactions or side effects associated with the usage of the medicinal product to the nearest NAFDAC office or via the E-reporting platforms provided on its official website.
The agency further urged the Marketing Authorisation Holder (Johnson & Johnson Company West Africa) to commence the batch recall, and the notification would be updated to the WHO Global Surveillance and Monitoring System (GSMS).
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