SAHPRA recalls Paediatric Syrup Due to Contamination Concerns

The South African Health Products Regulatory Authority (SAHPRA) has initiated a recall of two batches of Benylin Paediatric Syrup following reports of high levels of diethylene glycol detected in the product.

This decision came after SAHPRA recently received information from the Nigerian National Agency for Food and Drug Administration and Control (NAFDAC) about the contamination issue.

The affected batches, identified as 329304 and 329303, were manufactured by Kenvue (formerly Johnson and Johnson) and distributed in several countries including South Africa, Eswatini, Rwanda, Kenya, Tanzania, and Nigeria.

Dr Boitumelo Semete-Makokotlela, CEO of SAHPRA, emphasized the seriousness of the recall: “SAHPRA is recalling these two batches from the market due to reported high levels of diethylene glycol, with the potential to cause serious adverse events.”

Benylin Paediatric Syrup, described as a clear, bright red syrup with a raspberry odor and taste, is commonly used for treating coughs, congestion, hay fever, and other upper respiratory tract issues.

This precautionary measure underscores the importance of stringent regulatory oversight to safeguard consumer health against potential risks associated with medical products.

The recall, classified as a Class 1, Type A recall, signifies a serious product quality concern that could have severe consequences for consumers. SAHPRA has urged healthcare professionals and the public to immediately stop using the affected batches and return them through appropriate channels.

Diethylene glycol is known to be toxic to humans, potentially causing symptoms like abdominal pain, vomiting, diarrhea, altered mental state, and kidney injury, which can be life-threatening.

Consumers who have used the recalled batches and experience adverse reactions are encouraged to consult healthcare professionals and report incidents through the Med Safety App or by emailing adr@sahpra.org.za.

SAHPRA assured the public that this recall is limited to the specific batch numbers (329304 and 329303) and does not extend to other products with the same name.

“We are committed to prioritizing public health and safety through swift actions like this recall,” added Dr Semete-Makokotlela.