Zimbabwe Recalls Batches of Benylin Paediatric Syrup After Finding High Levels of Toxic Substance

THE Medicines Control Company of Zimbabwe -MCAZ has recalled two batches of Benylin Paediatric 100ml Syrup from shelves after a toxic substance, Diethylene glycol was recently found in the medicine.

In a statement, MCAZ director-general Richard Rukwata Monday said communication received from the National Agency for Food and Drug Administration (NAFDAC) of Nigeria indicated that Benylin Paediatric 100ml Syrup, batch numbers 329304 and 329303 manufactured by Johnson and Johnson, South Africa contained unacceptably high levels of this substance.

Diethylene glycol is a contaminant which is toxic for humans when consumed and 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 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 100ml Syrup, batch number 329304, manufactured by Johnson and Johnson, South Africa.

He said the South African Health Products Regulatory Authority (SAHPRA) and the manufacturer identified an additional batch that was affected bringing the affected batches to two, 329303 and 329304.

"According to NAFDAC, recent laboratory analysis has revealed unacceptably high levels of Diethylene glycol in this formulation," Rukwata said.

However, Rukwata reported that the affected batches were unlikely imported into the country even though it was registered in 2023 for use in Zimbabwe.

"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 for 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," he warned.

He urged the cooperation of all stakeholders to ensure the right of citizens to safe and good quality medicines was protected.

Meanwhile, the Authority says it will intensify its market surveillance activities through strict premises inspections and public awareness to ensure that these products are not circulated.

"MCAZ's mandate is to protect public health by ensuring that all medicines and medical devices on the market are safe, effective, and of good quality.

"MCAZ will continue to monitor the situation in line with the WHO guidelines. The Authority also urges members of the public to access medicines from licensed persons and premises for easier monitoring as the Authority and law enforcement agencies continue to work together to eradicate any substandard and falsified health products," part of his statement read.

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