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In a recent development, the South African Health Products Regulatory Authority (SAHPRA) has initiated a recall of two batches of Benylin Paediatric Syrup following a report from the Nigerian National Agency for Food and Drug Administration and Control (NAFDAC). The report highlighted elevated levels of diethylene glycol in a specific batch of the syrup, prompting immediate action from SAHPRA to ensure public safety.

The affected batches, identified as 329304 and 329303, have been distributed across several countries, including South Africa, Eswatini, Rwanda, Kenya, Tanzania, and Nigeria. Benylin Paediatric Syrup is a widely used medication indicated for cough relief, congestive symptoms, hay fever, and other upper respiratory tract conditions.

SAHPRA emphasizes that this recall is limited to the aforementioned batch numbers and does not extend to other batches or similar products. The regulatory authority is working closely with the manufacturer, Kenvue (formerly Johnson and Johnson), to conduct a thorough investigation while ensuring compliance with Good Manufacturing Practices.

It’s crucial for healthcare professionals and the public to discontinue the use of the recalled batches, remove them from inventory, and return them through the appropriate distribution channels promptly. This proactive measure aims to prevent potential health risks associated with diethylene glycol consumption, which can lead to severe adverse effects such as abdominal pain, vomiting, altered mental state, and acute kidney injury.

SAHPRA CEO, Dr Boitumelo Semete-Makokotlela, underscores the importance of recalls in safeguarding public health and addressing safety concerns promptly. Individuals who have used the affected batches and experience any adverse reactions are encouraged to consult healthcare professionals and report their experiences through designated channels like the Med Safety App or via email to adr@sahpra.org.za.

SAHPRA reassures the public that ongoing investigations and stringent regulatory measures are in place to maintain product safety and quality standards, ensuring the well-being of consumers across various healthcare sectors.

-The VIP Team

-SAHPRA