Independent tests confirm safety of Benylin

Kenvue welcomes 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 a recall in April 2014.  

Using the testing method recommended by the World Health Organization (WHO), SAHPRA independently tested the relevant batches. The recall was limited to batch numbers 329304 and 329303 of Benylin Paediatric Syrup which Kenvue also tested using the WHO-recommended method. Both these tests found no presence of diethylene glycol (DEG) or ethylene glycol (EG). There were no adverse events reported for batches 329303 and 329304. 

Kenvue follows strict and robust safety and quality processes to ensure that consumers can trust its products and the manufacturer stands by the safety of its Benylin® range. 

SAHPRA statement underlines safety standards

According to a statement released by SAHPRA on 5 June, the recall was implemented as a precaution to protect lives while the regulatory authority investigated the reported high levels of diethylene glycol. SAHPRA implements health product recalls as a crucial measure to address safety concerns or quality issues in the interest of public health. 

SAHPRA tested samples of the two affected batches of Benylin Paediatric Syrup through an independent laboratory using a method developed by the WHO 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 which were stored at the required temperature would not contain unacceptable levels of diethylene glycol.

SAHPRA also wishes to indicate 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 on the continent to which they were exported.

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. 

“SAHPRA will continue to closely monitor medical products that have the potential of containing unacceptable levels of diethylene glycol. We will also continue to address safety concerns or quality issues so that the health of the public is protected,” says SAHPRA CEO, Dr Boitumelo Semete-Makokotlela.