The Medicines Control Authority of Zimbabwe (MCAZ) has recalled from the market Benylin Paediatric syrup which is being manufactured by Johnson and Johnson in South Africa after the neighbouring country’s National Agency for Food and Drug Administration and Control (NAFDAC) declared it toxic for human consumption.
It was registered for use in Zimbabwe last year and has since been used as a prescriptive drug although youths abuse it with the intention to get a “high”.
The NAFDAC laboratory analysis revealed high levels of Diethylene glyco which is a contaminant that is toxic for humans when consumed.
Some of the complications associated with its use include abdominal pain, vomiting, diarrhoea, inability to pass urine, headache, altered mental state and acute kidney injury leading to death.
In a statement, MCAZ director-general Richard Rukwata said while the particular consignment identified to be toxic was not in Zimbabwe’s database, possibilities of illegal importation were very high.
“The Medicines Control Authority of Zimbabwe would like to inform all stakeholders of a critical communication received from National Agency for Food and Drug Administration of Nigeria regarding the recall of Benylin Paediatric 100ml Syrup, batch number 329304, manufactured by Johnson and Johnson, South Africa.
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“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.
“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,” Rukwata said.
He said the MCAZ would conduct strict market surveillance and investigations to end the access of the now “illegal deadly” drug. He called on the public to access medicines from verified and licensed pharmacies.
“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 it to children,” Rukwata said.
“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 activities through strict premises inspections and public awareness to ensure that these products are not circulated.
“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.”