Benylin Paediatric Cough Syrup Recalled In Zimbabwe, Several African Countries
The Medicines Control Authority of Zimbabwe (MCAZ) has advised members of the public against using Benylin Paediatric 100ml Syrup, batch numbers 329303 and 329304 manufactured by Johnson and Johnson, South Africa.
This comes after the National Agency for Food and Drug Administration (NAFDAC) of Nigeria raised alarm over the medicine after laboratory analysis showed that it contains unacceptably high levels of Diethylene glycol, a contaminant which is toxic for humans when consumed.
In a statement issued this Monday, April 15, MCAZ Director–General Richard Rukwata said those who may have accessed the medicine should immediately desist from administering it to children. Reads the statement:
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.
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.
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.
The cooperation 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 mandate of the MCAZ is to protect public health by ensuring that all medicines and medical devices on the market are safe, effective, and of good quality and will continue to monitor the situation in line with the WHO guidelines.
The Authority also urges members of the public to access medicines from licenced persons and premises for easier monitoring.
The Authority and law enforcement agencies continue to work together to eradicate any substandard and falsified health products.
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