The National Agency for Food and Drug Administration and Control (NAFDAC) has initiated a recall of Benylin Paediatric Syrup, manufactured by Johnson & Johnson, following the discovery of toxic levels of Diethylene glycol in the product, as indicated by recent laboratory tests. This substance is associated with acute oral toxicity in laboratory animals, and the recall notice was posted on NAFDAC's official website last Wednesday.
Product recalls are critical actions taken to mitigate safety issues and emergencies related to product safety. They involve the return of a specific batch or the entire production run of a product to the manufacturer, usually due to safety concerns, design defects, or labeling errors, as described by the online health resource, Science Direct.
NAFDAC has directed the marketing authorization holder of Benylin Paediatric syrup, Johnson and Johnson company, West Africa, to commence the recall process for the implicated batch. The information is also being communicated through the WHO Global Surveillance and Monitoring System.
Benylin Paediatric syrup is designed to alleviate cough and related symptoms in children between the ages of two and 12 years. However, it has been found to contain Diethylene glycol, which is harmful and potentially lethal to humans if consumed. Symptoms of its toxicity include abdominal pain, vomiting, diarrhea, changes in mental state, and acute kidney injury.
The product in question, produced by Johnson & Johnson in Cape Town, South Africa, is identified by batch number 329304, manufactured in May 2021, and set to expire in April 2024.
NAFDAC is cautioning importers, distributors, retailers, and consumers to remain vigilant in the supply chain to avoid the introduction, distribution, sale, and usage of substandard or contaminated regulated products.
Consumers who have the recalled product are advised to stop using it immediately and return it to the nearest NAFDAC office. Any adverse reactions observed after using the product should be reported to qualified healthcare professionals immediately.
