The Sunday News
The Medicines Control Authority of Zimbabwe (MCAZ) has directed the recall of Benylin Paediatric 100 ml Syrup, batch number 329304, manufactured by Johnson and Johnson of South Africa after the Nigerian National Agency for Food and Drug Administration (NAFDAC) red-flagged the product.
In a statement, MCAZ director general Richard Rukwata said a recent laboratory analysis according to NAFDAC has revealed unacceptably high levels of Diethylene glycol in the formulation.
Diethylene glycol is a contaminant which is toxic for humans when consumed. Rukwata, however, said the local import database does not show a record of the importation of the product and more specifically the mentioned batch.
“The Medicines Control Authority of Zimbabwe (MCAZ) would like to inform all stakeholders of a critical communication received from the National Agency for Food and Drug Administration (NAFDAC) of Nigeria regarding the recall of Benylin Paediatric 100 ml Syrup, batch number 329304, manufactured by Johnson and Johnson, South Africa.
“According to NAFDAC, recent laboratory analysis has revealed unacceptably high levels of Diethylene glycol in this formulation.
“Toxic effects can include abdominal pain, vomiting, diarrhoea, inability to pass urine, headache, altered mental state, and acute kidney injury, potentially leading to death,” he said.
Rukwata said the South African Health Products Regulatory Authority (SAHPRA) and the manufacturer identified an additional batch that is affected bringing the affected batches to two, namely 329303 and 329304.
Rukwata said while their organisation confirms that the product was registered in 2023 for use in Zimbabwe but not imported, the mentioned batches might 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.
Meanwhile, Rukwata said the authority will intensify its market surveillance activities through strict inspections of premises and public awareness to ensure that the products are not circulated.
“As the authority, we urge members of the public to access medicines from licenced persons and premises for easier monitoring. The authority and law enforcement agencies will continue to work together to eradicate any substandard and falsified health products,” he said.
New Ziana
