The National Agency for Food and Drugs Administration and Control (NAFDAC) has recalled Benylin Paediatrics Syrup, a popular cough medicine for children.
The product, manufactured by Johnson & Johnson, was said to contain an unacceptably high level of Diethylene glycol.
According to NAFDAC, the drug was found to cause acute oral toxicity in laboratory animals.
In a statement published on its website, NAFDAC said the decision was taken after a thorough laboratory analysis conducted on the product.
The statement partly reads: “The National Agency for Food and Drugs Administration and Control, NAFDAC, is notifying the public of the recall of one lot of Benylin Paediatrics Syrup manufactured by Johnson & Johnson, following recent toxicity findings in the laboratory on the product.
“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.
“Diethylene glycol is toxic to humans when consumed and can prove fatal. Toxic effects can include abdominal pain, vomiting, diarrhoea, inability to pass urine, headache, altered mental state, and acute kidney injury which may lead to death.
“The details of the affected product are shown below:
“Product name: Benylin Paediatric; manufacturer: Johnson 241, Main Road, Retreat Cape Town, 7945.
“Importer: Johnson and Johnson Company West Africa, Batch number, 329304. Manufacturing date: May 2021, and Expiry date, April 2024.
“NAFDAC implores 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.
“Similarly, healthcare professionals and patients are also encouraged 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.”
