The National Agency for Food and Drugs Administration and Control (NAFDAC) has announced its recall of a popular cough medicine for children, Benylin Paediatrics Syrup.
Produced by Johnson & Johnson, NAFDAC said in a statement on its website that the action was taken following recent toxicity findings in the laboratory on the product.
It disclosed that laboratory analysis conducted on the product showed that it contains an unacceptable high level of Diethylene glycol and was found to cause 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.
The agency explained that Diethylene glycol is toxic to humans when consumed and can prove fatal.
It said toxic effects could include abdominal pain, vomiting, diarrhoea, inability to pass urine, headache, altered mental state, and acute kidney injury which may lead to death.
NAFDAC implored 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.
It called on anyone in possession of the product “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.
Healthcare professionals and consumers are advised to report any suspicion of substandard and falsified medicines to the nearest NAFDAC office,” NAFDAC said.
Similarly, it encouraged healthcare professionals and patients to report adverse events or side effects related to the use of the medicinal product to the nearest NAFDAC office, or through the use of the E-reporting platforms available on the NAFDAC website.
Meanwhile, NAFDAC said it “has directed the marketing authorisation Holder (Johnson and Johnson company West Africa) to initiate the recall of the batch and the notice will also be uploaded to the WHO Global Surveillance and Monitoring System (GSMS).”
