NAFDAC Recalls Benylin Syrup, Declares It Toxic

The National Agency for Food and Drugs Administration and Control (NAFDAC) has issued a recall for Benylin Paediatric Syrup, manufactured by Johnson & Johnson. The decision came after a laboratory analysis revealed alarming levels of Diethylene glycol, a substance known to be toxic to humans.

According to NAFDAC’s announcement on its website, the syrup exhibited an unacceptable concentration of Diethylene glycol, which has been linked to acute oral toxicity in laboratory animals. Symptoms of toxicity include abdominal pain, vomiting, diarrhea, altered mental state, and even acute kidney injury, which could lead to fatal outcomes.

Benylin Paediatric Syrup, commonly used to alleviate cough and congestion symptoms in children aged two to 12 years, was manufactured by Johnson & Johnson in Cape Town, South Africa. Identified with batch number 329304 and manufactured in May 2021, the product is slated to expire this month, April 2024.

As a precautionary measure, NAFDAC has urged importers, distributors, retailers, and consumers to exercise utmost vigilance and avoid the sale or use of the contaminated product. They emphasized the importance of sourcing medical products only from authorized suppliers and advised immediate discontinuation of the use or sale of Benylin Syrup.

Furthermore, NAFDAC encouraged healthcare professionals and consumers to promptly report any suspicion of substandard or falsified medicines to the nearest NAFDAC office. They also directed the Marketing Authorization Holder, Johnson & Johnson Company West Africa, to initiate the recall process for the affected batch.

In addition, NAFDAC assured the public that the recall notice would be disseminated through the WHO Global Surveillance and Monitoring System (GSMS), ensuring global awareness of the issue.

In light of this development, healthcare professionals and patients are urged to report any adverse events or side effects associated with the use of Benylin Syrup to the nearest NAFDAC office or through the agency’s E-reporting platforms available on its website. Vigilance and cooperation from all stakeholders are crucial in safeguarding public health against the risks posed by substandard medical products.