HARARE – The Medicines Control Authority of Zimbabwe (MCAZ) has recalled, with immediate effect, Benylin Paediatric Syrup on fears that toxic batches of the cough medicine may have found their way into Zimbabwe’s market.
In a statement issued on Monday, MCAZ the decision was a precautionary taken by the medicine regulator after the product was recalled in Nigeria and few other countries.
The National Agency for Food and Drug Administration (NAFDAC) of Nigeria recalled Benylin Paediatric 100ml syrup batch number 329304, manufactured by Johnson and Johnson, South Africa.
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.
“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,” said MCAZ.
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.
MCAZ urged the public to report if they are in possession of, or have come across the blacklisted product.
The authority also urged the public not to administer the condemned medicine on their children.
In the meantime, MCAZ will be conducting surveillance through strict premises inspections and public awareness.
