Sahpra clears Benylin paediatric cough syrup after recall over ‘toxic chemical’ fears

Published Jun 5, 2024


The South African Health Products Regulatory Authority (Sahpra) says no traces of diethylene glycol have been found in any of the recalled batches of Benylin paediatric syrup.

The authority in April recalled two batches of the locally-produced cough syrup following reports in Nigeria and Kenya, claiming that there were high levels of the potentially lethal poisonous chemical that could lead to illness and even death in children.

In a statement on Wednesday, Sahpra said as part of the investigation of the reported high levels of diethylene glycol, Sahpra tested samples of the two affected batches of Benylin Paediatric syrup through an independent laboratory and a method developed by the World Health Organization for testing products for the presence of diethylene glycol.

"The tests did not find traces of diethylene glycol in the recalled batches. This indicates that units of batches 329303 and 329304 that were stored at the required temperature would not contain unacceptable levels of diethylene glycol," said Sahpra chief executive officer, Dr Boitumelo Semete-Makokotlela.

She further stated that there is no record of any adverse drug reactions relating to diethylene glycol for the two recalled batches in South Africa or anywhere else where they were exported to on the continent.

Semete-Makokotlela explained that Sahpra is mandated to regulate and apply due diligence to health products to ensure that products in circulation in South Africa and those exported from SAHPRA-licensed manufacturers are safe for public consumption.

"Sahpra applies this due diligence throughout the product life cycle, from registration through to post-market monitoring. We will continue to closely monitor medical products that have the potential of containing unacceptable levels of diethylene glycol. And we will continue to address safety concerns or quality issues so that the health of the public is protected," Semete-Makokotlela said.

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