The National Agency for Food and Drugs Administration and Control (NAFDAC) has ordered the recall of Benylin Paediatrics Syrup, manufactured by Johnson & Johnson, following recent findings of toxicity in laboratory tests conducted on the product.
In a statement released on Wednesday, NAFDAC revealed that laboratory analysis revealed an unacceptably high level of Diethylene glycol in the syrup, which was found to cause acute oral toxicity in laboratory animals.
The agency directed the marketing authorisation holder of Benylin Paediatric syrup (Johnson and Johnson company, West Africa) to initiate the recall of the affected batch. The recall notice will also be uploaded to the WHO Global Surveillance and Monitoring System.
Benylin Paediatric syrup, indicated for the relief of cough and allergic conditions in children aged two to 12 years, poses serious health risks due to the presence of Diethylene glycol, which is toxic to humans and can be fatal.
The product, manufactured by Johnson & Johnson in Cape Town, South Africa, with batch number 329304, was produced in May 2021 and is set to expire this month, April 2024.
NAFDAC urged importers, distributors, retailers, and consumers to exercise caution and vigilance to prevent the importation, distribution, sale, and use of substandard products. It emphasized the importance of obtaining medical products from authorized/licensed suppliers and advised immediate discontinuation of sale or use of the recalled product.
Healthcare professionals and consumers were urged to report any suspicion of substandard and falsified medicines to the nearest NAFDAC office or via email. Additionally, anyone witnessing adverse reactions after using the product was advised to seek immediate medical attention.
