By Staff Reporter
The Medicines Control of Zimbabwe has issued a recall of Benylin Paediatric 100ml Syrup, manufactured by Johnson and Johnson, South Africa, as a precautionary measure after two batch numbers of the product was flagged by their counterparts, the National Agency for Food and Drug Administration (NAFDAC) from Nigeria and South African Health Products Regulatory Authority (SAHPRA).
According to the MCAZ statement, whilst the mentioned batch numbers has no trace of being imported into the country, the authority has seen it necessary to recall the medicine as it factors in chances of entry through illegal means.
“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 the Authority.
NAFDAC, which first flagged batch 329304 after laboratory analysis said ‘unacceptably high levels of Diethylene glycol in this formulation. The same was also found by SAHPRA which identified batch number 329304.
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.
The medicine regulatory body urged the public to work together with them and report any trace of the recalled medication.
“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.”