The South African Health Products Regulatory Authority (SAHPRA) has initiated a recall for two batches of Kenvue’s (previously Johnson and Johnson) Benylin paediatric syrup, indicated for cough relief in children.
The recall is in response to detecting high levels of diethylene glycol in the medicine, which poses serious health risks.
Go deeper with GlobalData
SAHPRA classified the country-wide recall as Class 1, Type A – a severe product quality concern that could have dire consequences.
The issue came to light following a report from the Nigerian National Agency for Food and Drug Administration and Control (NAFDAC), which found the toxic substance in a batch of syrup.
Working with Kenvue, SAHPRA has identified the impacted batch numbers as 329303 and 329304. These batches were distributed across Eswatini, Kenya, Nigeria, Rwanda, South Africa and Tanzania.
See Also:
Benylin paediatric syrup is a raspberry-flavoured red syrup, packaged in 100ml amber glass bottles with a plastic measuring cup, to relieve cough, congestion, hay fever and allergies affecting the upper respiratory tract.
How well do you really know your competitors?
Access the most comprehensive Company Profiles on the market, powered by GlobalData. Save hours of research. Gain competitive edge.
Thank you!
Your download email will arrive shortly
Not ready to buy yet? Download a free sample
We are confident about the unique quality of our Company Profiles. However, we want you to make the most beneficial decision for your business, so we offer a free sample that you can download by submitting the below form
By GlobalDataSAHPRA has urged healthcare professionals and the public to cease using the affected batches, remove them from inventory and return them through normal distribution channels immediately.
The recall extends to hospitals, retail outlets, healthcare professionals, authorised prescribers and individual customers or patients.
Diethylene glycol is highly toxic if ingested and can lead to symptoms such as pain in the abdomen, vomiting, diarrhoea, headaches and acute kidney injury, potentially resulting in death.
The authority emphasised that the recall is batch-specific and does not necessarily apply to other batches or similar products.
SAHPRA CEO Dr Boitumelo Semete-Makokotlela stated: “As a national regulatory authority, the recalling of medical products is a crucial measure to address safety concerns or quality issues so that we protect the health of the public.
“SAHPRA is recalling these two batches from the market due to reported high levels of diethylene glycol, with the potential to cause serious adverse events.”
