By Staff Reporter
The Medicines Control Authority of Zimbabwe (MCAZ) has issued a critical recall notice following a communication received from the National Agency for Food and Drug Administration (NAFDAC) of Nigeria.
The alert concerns the recall of Benylin Paediatric 100ml Syrup, batch numbers 329303 and 329304, manufactured by Johnson and Johnson, South Africa.
According to MCAZ director general Richard Rukwata, the recall was prompted by recent laboratory analysis revealing unacceptably high levels of Diethylene glycol in the formulation.
“According to NAFDAC, recent laboratory analysis has revealed 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.
“Additionally, 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. While the Authority confirms that this product was registered in 2023 for use in Zimbabwe, our import database does not show a record of the importation of this product and more specifically these two batches,” said Rukwata
He added “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. In the unlikely event that members of the public are in possession of and/or come across this product, please notify the Authority and/or healthcare provider immediately and desist from administering them to children.”
As a precautionary measure, the MCAZ urges the public to notify the Authority or healthcare providers immediately if they come across these products and refrain from administering them to children.
Rukwata said MCAZ will intensify market surveillance activities through strict premises inspections and public awareness campaigns to prevent the circulation of these products.
He urged members of the public to access medicines from licensed persons and premises for easier monitoring saying the Authority, along with law enforcement agencies, remains vigilant in eradicating substandard and falsified health products.
