The National Agency for Food and Drugs Administration and Control (NAFDAC) has initiated a recall of Benylin Paediatrics Syrup produced by Johnson & Johnson due to recent findings of toxicity in laboratory tests conducted on the product.
According to NAFDAC, analysis of the syrup revealed an alarmingly high level of Diethylene glycol, a substance known to cause acute oral toxicity in laboratory animals. The agency made this disclosure on its website on Wednesday, highlighting the seriousness of the situation.
A product recall is a crucial measure to address safety concerns and emergencies associated with products. It involves returning a batch or entire production run of a product to the manufacturer, typically due to safety issues, design flaws, or labeling errors.
NAFDAC has directed the marketing authorization holder of Benylin Paediatric Syrup, Johnson & Johnson Company, West Africa, to initiate the recall of the affected batch. The notice of recall will also be disseminated through the WHO Global Surveillance and Monitoring System.
Benylin Paediatric Syrup, indicated for relieving cough and congestion symptoms in children aged two to 12 years, poses significant risks due to the presence of Diethylene glycol. This compound is toxic to humans and can result in severe health complications, including abdominal pain, vomiting, diarrhea, altered mental state, and acute kidney injury, potentially leading to death.
The affected product, manufactured by Johnson & Johnson in Cape Town, South Africa, bears batch number 329304 and was produced in May 2021, with an expiration date of April 2024.
NAFDAC advises importers, distributors, retailers, and consumers to exercise utmost caution and vigilance in the supply chain to prevent the importation, distribution, sale, and use of substandard or contaminated regulated products. It emphasizes the importance of obtaining medical products from authorized and licensed suppliers and urges careful inspection of product authenticity and physical condition.
Individuals in possession of the recalled product are urged to discontinue its sale or use immediately and submit remaining stock to the nearest NAFDAC office. Any adverse reactions or events following the use of this product should be promptly reported to qualified healthcare professionals for medical attention.
Healthcare professionals and consumers are encouraged to report suspicions of substandard or falsified medicines to NAFDAC and to report adverse events or side effects related to the use of medicinal products through various channels provided by the agency.
NAFDAC plays a vital role in regulating and controlling the manufacture, importation, distribution, advertisement, sale, and use of various products, including food, drugs, cosmetics, medical devices, and chemicals.
