The South African Health Products Regulatory Authority (SAHPRA) has recalled two batches of Benylin paediatric syrup in response to the Nigerian National Agency for Food and Drug Administration’s alert.
This comes after high levels of diethylene glycol were found in a batch of the medicine with batch numbers 329304 and 329303, which has an expiration date of April 2024.
SAHPRA says the recall comes while it investigates the affected batches, which were distributed to several African countries, including South Africa, Kenya, Tanzania and Nigeria.
‘The public is reminded that the recall is limited to two batches, being 329304 and 329303, and is urged not to panic regarding the range baring the same name,’ SAHPRA said.
[READ] SAHPRA recalls two batches of Benylin Paediatric Syrup
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— SAHPRA (@SAHPRA1) April 13, 2024
According to News24, Nigeria’s National Agency for Food and Drug Administration and Control (NAFDAC) disclosed that laboratory analysis of the cough syrup showed an unacceptably high level of diethylene glycol, which has been linked to acute oral toxicity in laboratory animals and poses serious risks to human health, including symptoms like abdominal pain, vomiting and acute kidney injury.
Kenya’s health regulator has also initiated a recall of the syrup following these revelations.
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The Benylin brand, previously under Johnson & Johnson, is now managed by Kenvue, a separate entity formed after the spin-off of Johnson & Johnson’s consumer health business last year.
Kenvue is actively engaging with regulatory authorities to understand the situation and conduct a thorough assessment of safety and quality.
In response to inquiries about the availability of this batch in South Africa, Kenvue did not confirm specific details but emphasised its commitment to customer health and safety.
The company is urgently investigating the matter to ensure the highest standards of product quality and regulatory compliance.
It is important for consumers to be aware of this development and exercise caution if they have any products from the affected batch.
NAFDAC in Nigeria has advised individuals with bottles from the recalled batch to discontinue use and submit them to the nearest regulatory office.
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