MCAZ issues urgent recall of children’s cough syrup over toxic substance alert
HARARE — The Medicines Control Authority of Zimbabwe (MCAZ) has issued an urgent recall for two batches of Benylin Paediatric Syrup due to the detection of dangerously high levels of Diethylene glycol, a toxic substance that can lead to fatal consequences in children.
Healthcare professionals and the public have been advised to cease use, remove the product from their inventory, and return it to their suppliers immediately.
Although MCAZ insist they have not found evidence of legal importation for these batches in their database, the porous nature of Zimbabwe’s borders, which currently facilitates a web of underground illicit distribution of medicines and drugs, has prompted the Authority to recall the product.
“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,” said MCAZ director general Richard Rukwata on Monday.
MCAZ, responsible for ensuring the safety, efficacy, and quality of medicines and medical devices, confirmed the registration of the product in Zimbabwe in 2023.
However, they insist the batches in question may have entered Zimbabwe’s healthcare system through illegal means and unregulated channels.
The recal follows a similar action by the South African Health Products Regulatory Authority (SAHPRA) and was initiated after an alert from the Nigerian National Agency for Food and Drug Administration and Control (NAFDAC).
NAFDAC’s laboratory analysis identified the presence of Diethylene glycol in batch number 329304. SAHPRA and the manufacturer later discovered an additional affected batch, number 329303.
“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, diarrhea, inability to pass urine, headache, altered mental state, and acute kidney injury, potentially leading to death,” elaborated Rukwata.
The Authority urged the public to report any findings of the product and to refrain from administering it 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,” Rukwata added.
