The Medicines Control Authority of Zimbabwe (MCAZ) has banned the sale of Benylin Paediatric Syrup, which is manufactured by Johnson and Johnson in South Africa, after authorities in Nigeria found toxins in two batches of the cough syrup.
There are no records of any imports of the product, approved in 2023 in Zimbabwe, but MCAZ is worried that some of the product might be smuggled into the country.
The red flag was raised by the National Agency for Food and Drug Administration (NAFDAC) of Nigeria regarding its recall of Benylin Paediatric 100ml Syrup, batch number 329304, manufactured by Johnson and Johnson South Africa, from Nigerian shelves.
Recent laboratory analysis by NAFDAC found unacceptably high levels of diethylene glycol in this formulation. Diethylene glycol is a contaminant which is toxic for humans when consumed. Toxic effects can include abdominal pain, vomiting, diarrhoea, inability to pass urine, headache, altered mental state, and acute kidney injury, potentially leading to death.
The South African Health Products Regulatory Authority (SAHPRA) and the manufacturer identified an additional batch that is affected bringing the affected batches to two; 329303 and 329304.
MCAZ director general Mr Richard Rukwata urged members of the public to refrain from using this product.
"In the unlikely event that members of the public own or come across this product, please notify the authority or healthcare provider immediately and desist from administering them to children," said MCAZ in a statement.
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"The co-operation of all stakeholders is essential in ensuring the right of citizens to safe and good quality medicines is protected.
"Meanwhile, the authority will intensify its market surveillance through strict premises inspections and public awareness to ensure that these products are not circulated."
MCAZ said it feared that the contaminated batches could enter the market through illegal channels, hence 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."
MCAZ is mandated to protect public health by ensuring that all medicines and medical devices on the market are safe, effective, and of good quality and will continue to monitor the situation in line with WHO guidelines.
The authority also urges members of the public to access medicines from licensed persons and premises for easier monitoring. The Authority and law enforcement agencies continue to work together to eradicate any substandard and falsified health products.
