The National Agency for Food and Drugs Administration and Control (NAFDAC) has ordered the recall of Benylin Paediatrics Syrup manufactured by Johnson & Johnson due to recent findings of toxicity in laboratory tests.
According to NAFDAC, laboratory analysis revealed that the cough syrup contained an unacceptably high level of Diethylene glycol, a toxic substance, which caused acute oral toxicity in laboratory animals.
The announcement was made by NAFDAC on its official website on Wednesday, raising concerns about the safety of the product, particularly for children.
The recall directive was issued to the marketing authorization holder, Johnson & Johnson Company West Africa, with instructions to initiate the recall of the affected batch. Additionally, NAFDAC stated that the recall notice would be uploaded to the WHO Global Surveillance and Monitoring System.
Benylin Paediatric syrup, intended for cough relief and treatment of hay fever and allergic conditions in children aged two to 12 years, poses serious health risks due to the presence of Diethylene glycol. Symptoms of toxicity include abdominal pain, vomiting, diarrhoea, headache, altered mental state, and acute kidney injury, which can be fatal.
The affected product, bearing batch number 329304, was manufactured in May 2021 in Cape Town, South Africa, and is set to expire in April 2024.
NAFDAC advised importers, distributors, retailers, and consumers to exercise caution and vigilance within the supply chain to prevent the importation, distribution, sale, and use of substandard or contaminated products. It emphasized the importance of obtaining medical products from authorized and licensed suppliers and urged immediate discontinuation of the sale or use of the recalled product.
Healthcare professionals and consumers were urged to report any adverse reactions or suspicions of substandard or falsified medicines to the nearest NAFDAC office or through designated reporting channels. NAFDAC’s regulatory oversight extends to food, drugs, cosmetics, medical devices, packaged water, chemicals, and detergents, aimed at safeguarding public health and safety.
