The South African Health Products Regulatory Authority (SAHPRA) has taken swift action in response to concerning reports regarding two batches of Benylin paediatric cough syrup. Here’s what you need to know about this developing situation:
Recall Initiated
SAHPRA acted promptly after receiving notification from the Nigerian National Agency for Food and Drug Administration and Control (NAFDAC) regarding high levels of diethylene glycol found in a batch of Benylin paediatric cough syrup. Diethylene glycol is a toxic substance to humans and can have severe, even fatal, consequences if ingested.
Health Risks
The presence of diethylene glycol in the affected batches poses serious health risks. Symptoms of toxicity include abdominal pain, vomiting, diarrhea, headache, altered mental state, and acute kidney injury. These adverse effects underscore the urgency of the recall to prevent harm to consumers.
[READ] SAHPRA recalls two batches of Benylin Paediatric Syrup
— SAHPRA (@SAHPRA1) April 13, 2024
The public is reminded that the recall is limited to two batches and should not panic regarding the range of products bearing the same name.https://t.co/BK15iISxZF#SAHPRA#productrecall#BenylinPaediatricSyrup
Collaborative Response
SAHPRA promptly engaged with the manufacturer, Kenvue, formerly known as Johnson and Johnson, to address the issue. As a result of these discussions and in the interest of public safety, it was decided to recall the affected batches while investigations are ongoing. The affected batch numbers are 329304 and 329303.
Extent of Distribution
The impact of this recall extends beyond South Africa, with the affected batches distributed to several countries including Eswatini, Rwanda, Kenya, Tanzania, and Nigeria. This widespread distribution necessitates coordinated efforts to mitigate risks and ensure consumer safety across borders.
Public Advisory
SAHPRA CEO, Dr Boitumelo Semete-Makokotlela, emphasised the importance of the recall in safeguarding public health. Consumers are urged not to panic, as the recall is limited to specific batches. It’s crucial for healthcare professionals and the public to discontinue the use of the recalled batches and return them through appropriate channels.
Severity of Recall
The recall is classified as a Class 1, Type A recall, indicating a serious product quality concern with potentially severe consequences. This classification underscores the critical importance of swift and comprehensive action to protect consumers.
Reporting Adverse Reactions
Individuals who have consumed the affected batches and experienced adverse reactions are encouraged to consult their healthcare professionals immediately. Reporting adverse events is vital for ongoing monitoring and response. Reports can be submitted through the Med Safety App or via email to adr@sahpra.org.za.
Continued Vigilance
This incident highlights the ongoing importance of rigorous regulatory oversight and surveillance in ensuring the safety and efficacy of medical products. SAHPRA remains committed to upholding the highest standards of public health protection and will continue to investigate and address any potential risks to consumers.
The recall of two batches of Benylin paediatric cough syrup underscores the proactive measures taken by regulatory authorities to safeguard public health. With swift action and collaborative efforts between regulatory bodies and manufacturers, the impact of potential health risks can be mitigated. As investigations continue, consumers are reminded to remain vigilant and heed official advisories to ensure their safety.
