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Saprah reassures public following Benylin recall
Results from independent laboratories revealed no traces of diethylene glycol in the recalled batches of Benylin®.
Saprah reassured the public that there have been no recorded adverse drug reactions associated with diethylene glycol in the recalled batches. Image: Adobe Stock
The South African Health Products Regulatory Authority (Sahpra) recalled two batches of Benylin® Paediatric Syrup (batch numbers 329303 and 329304) on 13 April 2024.
This precautionary measure was prompted by concerns raised by the Nigerian National Agency for Food and Drug Administration and Control (Nafdac) regarding elevated levels of diethylene glycol.
As the national regulatory authority for health products in South Africa, Sahpra views product recalls as essential to safeguard public health in response to safety or quality issues, said Dr Boitumelo Semete-Makokotlela, CEO of Sahpra.
Hence, Sahpra conducted rigorous testing of samples from the affected batches using a method endorsed by the World Health Organization (WHO). Results from independent laboratories revealed no traces of diethylene glycol in the recalled batches of Benylin®.
Furthermore, Saprah reassured the public that there have been no recorded adverse drug reactions associated with diethylene glycol in the recalled batches, neither in South Africa nor in any export destination across the continent. With a mandate to ensure the safety of health products throughout their lifecycle, Sahprah remains vigilant in monitoring and addressing potential safety concerns, stressed Semete-Makokotlela.
Lastly, she affirmed the authority’s commitment to ongoing vigilance. Sahpra will take action to protect public health against potential risks associated with health products.
Kenvue confirms safety of Benylin®
Kenvue, the producers of Benylin® welcomed Sahpra’s statement reaffirming the safety of the product.
Additional to Sahpra’s tests, Kenvue conducted tests on batches 329303 and 329304 using the WHO-recommended method. Both batches yielded results indicating the absence of diethylene glycol or ethylene glycol. There were no reports of adverse events associated with batches 329303 and 329304.
Furthermore, the company said it adheres to strict and robust safety and quality procedures. This is done to ensure consumer trust in their products and affirmed the safety of the Benylin® range.
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