The South African Health Products Regulatory Authority (SAHPRA) has released the results of its investigation following the recall of Benylin paediatric syrup, revealing that there were no traces of diethylene glycol found.
The precautionary recall of two batches of Benylin Paediatric Syrup (batch numbers 329303 and 329304) was in response to reported high levels of diethylene glycol in an alert by the Nigerian National Agency for Food and Drug Administration and Control (NAFDAC).
SAHPRA has indicated 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 on the continent.
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, using a method developed by the World Health Organisation (WHO) for testing products for the presence of diethylene glycol.
It revealed that the tests did not find traces of diethylene glycol in the recalled batches. This indicates that units of batches 329303 and 329304 that stored at the required temperature would not contain unacceptable levels of diethylene glycol.
“SAHPRA will continue to closely monitor medical products that have the potential to contain 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,” said SAHPRA CEO, Dr Boitumelo Semete-Makokotlela.
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 post-market monitoring.
Kenvue, the makers of BENYLIN, reacted in a statement that read: “We welcome the statement by the South African Health Product Regulatory Authority (SAHPRA) reaffirming the safety of the batches of Benylin® Paediatric Syrup that were subject to the recall.
“Using the testing method recommended by the World Health Organisation, SAHPRA independently tested the relevant batches. Kenvue also tested batches 329303 and 329304 using the WHO-recommended method. Both of these tests found no presence of diethylene glycol (DEG) or ethylene glycol (EG). There were no adverse events reported for batches 329303 and 329304.
“We follow strict and robust safety and quality processes to ensure that consumers can trust our products and stand by the safety of our Benylin range.”
The Star
anita.nkonki@inl.co.za