The national agency for food and Drugs Administration and Control (NAFDAC) has announced the recall of popular Benylin Pediatrics syrup manufactured by American pharmaceutical giant, Johnson & Johnson, following what it calls the recent “toxicity findings” in the laboratory test on the product.
NAFDAC said laboratory analysis conducted on the product showed that it contained an unacceptably 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, diarrhea, inability to pass urine, headache, altered mental state, and acute kidney injury which may lead to death,” the statement reads.
The agency made this disclosure on its website on Wednesday, April 10th, 2024. It said it had directed the marketing authorisation holder of Benylin pediatric syrup (Johnson and Johnson company, West Africa) to initiate the recall of the batch adding that the notice will also be uploaded to the World Health Organization (WHO’s) global surveillance and monitoring system, (GSMS).
The details of the product show it was 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.
NAFDAC, has therefore called on 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,” the agency warned.
