The National Agency for Food and Drugs Administration and Control has issued a recall for Benylin Paediatrics Syrup, which is manufactured by Johnson & Johnson.
This action was taken after recent laboratory tests found high levels of Diethylene glycol in the product, which can cause acute oral toxicity in animals.
NAFDAC announced this information on its website on Wednesday. A product recall is a crucial way to manage risks related to product safety issues and emergencies.
According to Science Direct, a product recall involves returning a batch or entire production run of a product to the manufacturer due to safety concerns, design flaws, or labeling errors.
NAFDAC has instructed the marketing authorization holder of Benylin Paediatric syrup (Johnson and Johnson company, West Africa) to start the recall process for the affected batch. The notice will also be shared on the WHO Global Surveillance and Monitoring System.
“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,” NAFDAC said.
The product details indicate that it was made by Johnson & Johnson in Cape Town, South Africa.
It was produced in May 2021 with batch number 329304 and is set to expire in April 2024.
NAFDAC is urging importers, distributors, retailers, and consumers to be cautious and vigilant in the supply chain to prevent the importation, distribution, sale, and use of substandard (contaminated) regulated products.
They emphasize that all medical products should be purchased from authorized/licensed suppliers, and their authenticity and physical condition should be thoroughly 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 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 on 0800-162-3322 or via email: sf.alert@nafdac.gov.ng
“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 www.nafdac.gov.ng or via the Med-safety application available for download on android and IOS stores or via e-mail on pharmacovigilance@nafdac.gov.ng,” it added.
NAFDAC oversees the manufacturing, importation, exportation, distribution, advertising, sale, and use of food, drugs, cosmetics, medical devices, packaged water, chemicals, and detergents.
