Azra Hoosen | ah@radioislam.co.za
7 June 2024 | 10:30 CAT
2 min read

South African health authorities have cleared Benylin Paediatric syrup of any toxin contamination after conducting independent tests on two affected batches. This comes after recalls were issued in five African countries due to reports of high levels of diethylene glycol in the syrup, which can be harmful.

Although the affected batches were produced in South Africa, tests revealed no traces of the toxin, reassuring the public about the product’s safety.

The CEO of the SA Health Products Regulatory Authority (SAHPRA) emphasised ongoing monitoring to ensure public health protection.

In an interview with Radio Islam, Deon Poovan, Senior Manager of SAHPRA’s Inspectorate and Regulatory Compliance, clarified that due to the severity of diethylene glycol contamination in medicines, SAHPRA initiated a precautionary recall.

“From initial investigations, we found that the batch that Nigeria found was linked to another batch, which is why you see two batch numbers of Benylin Paediatric being recalled by SAHPRA. Since then, SAHPRA has conducted its own independent testing of samples of these two batches and found they do not contain traces of diethylene glycol and, therefore safe for consumption,” he said.

According to Poovan, the recall only pertained to two specific batches, emphasising that Benylin Paediatric consistently adheres to good manufacturing practices. Additionally, he noted that the manufacturer has cooperated fully with SAHPRA, conducting their own rigorous testing and root-cause investigations.

It has been reported that no adverse events have so far been reported in South Africa or other African countries relating to the syrup, though Kenya, Rwanda, Tanzania and Zimbabwe also issued recalls.

“There is no information about what happened in Nigeria and Kenya. As a regulator, we are letting our public know what we found as part of our independent investigation,” said Poovan.

Additionally, Kenvue, the company that now owns the Benylin brand following its spinoff from J&J last year, stated that their independent tests of the recalled batches revealed no presence of either diethylene glycol or another closely linked toxin, ethylene glycol.

LISTEN to the full interview with Ml Sulaimaan Ravat and SAHPRA’s Deon Poovan, here.