National Agency for Food and Drugs Administration and Control (NAFDAC) 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.
“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,” 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).
NAFDAC, however, implored 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.
It said all medical products must be obtained from authorised/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 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,” it added.
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.
