Benylin Paediatric Syrup Banned due to Toxins
The Medicines Control Authority of Zimbabwe (MCAZ) has taken a decisive step to ban the sale of Benylin Paediatric Syrup, manufactured by Johnson and Johnson in South Africa. This action comes in response to the discovery of toxins in two batches of the cough syrup by Nigerian authorities, prompting concerns about its potential presence in Zimbabwe.
The National Agency for Food and Drug Administration (NAFDAC) of Nigeria raised the alarm by recalling batch number 329304 of Benylin Paediatric 100ml Syrup, manufactured by Johnson and Johnson South Africa, from Nigerian store shelves.
Laboratory analysis conducted by
NAFDAC revealed alarmingly high levels of diethylene glycol, a toxic contaminant. Diethylene glycol is known to pose serious risks to human health, including symptoms such as abdominal pain, vomiting, diarrhea, urinary difficulties, headaches, mental impairment, acute kidney injury, and even death.
Following investigations by the South African Health Products Regulatory Authority (SAHPRA) and the manufacturer, an additional affected batch was identified, bringing the total to two: 329303 and 329304. In light of these findings, Mr. Richard Rukwata, the director general of MCAZ, issued a strong advisory urging the public to refrain from using the product.
MCAZ emphasized the importance of cooperation among all stakeholders to protect citizens’ right to safe and high-quality medicines. As a precautionary measure, the authority will intensify market surveillance through stringent premises inspections and public awareness campaigns to prevent the circulation of these potentially harmful products.
While MCAZ acknowledges that the product was registered for use in Zimbabwe in 2023, their import database does not show any records of importing these specific batches. How ever they expressed concerns that the contaminated batches may enter the market through illegal channels, which prompted the ban.
“While the authority confirms that this product was registered in 2023 for use in Zimbabwe, our import database does not show a record of imports of this product and more specifically these two batches,” said Mr Rukwata.
“However, there is a concern that through illegal means, the aforementioned batches of Benylin Paediatric Syrup may find their way into the local market. As a precautionary measure, the Authority is issuing a recall notice of this product.”
The authority will continue to monitor the situation in accordance with guidelines provided by the World Health Organization (WHO).
MCAZ also urges the public to obtain medicines only from licensed individuals and premises, as this facilitates easier monitoring of the products. The authority maintains a close collaboration with law enforcement agencies to combat the presence of substandard and falsified health products, ensuring the safety and well-being of the population.
