World Health Organization, (WHO) has announced that a contaminated batch of Benylin Paediatric Syrup is no longer available in the African countries where it was sold.
Nigeria recently issued a recall for a group of children’s cough and allergy medicines due to the discovery of high levels of the toxin, diethylene glycol.
Five additional African nations have also removed the product from circulation – Kenya, Rwanda, Tanzania, Zimbabwe, and South Africa, the country where the medication was manufactured.
Johnson & Johnson (JNJ.N) produced the recalled batch of Benylin syrup in South Africa in May 2021. However, Kenvue (KVUE.N) currently owns the brand following a spin-off from J&J last year.
Requests for comment regarding the recall have been directed to Kenvue by J&J. In a statement sent via email, Kenvue mentioned that tests conducted on the batch recalled by Nigeria did not reveal the presence of diethylene or ethylene glycol. The company stated that it is collaborating with the authorities to address the situation.
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Diethylene glycol can cause acute kidney failure and alongside another related toxin, ethylene glycol, has been linked to the deaths of more than 300 children in Cameroon, Gambia, Indonesia, and Uzbekistan since 2022 after being found in medicines made in India and Indonesia.
No children have been reported hurt or killed in the latest incident.
The WHO, which has warned countries and companies to be vigilant about the ongoing risk of contamination, said on Friday it was “likely” to issue a broader alert about Benylin. However, on Monday the health agency said it no longer had immediate plans to do so after getting more information at the end of the week.
A spokesperson said; “considering that this batch is no longer on the market in any of the impacted countries and it has been consumed with no apparent reports of adverse effects, we believe that there is no immediate public health risk,”
Backstory
WHO is poised to escalate its warning concerning contaminated children’s cough syrup manufactured by Johnson & Johnson (JNJ.N), following its discovery in Nigeria two weeks ago.
The Nigerian regulatory agency initiated a recall of a batch of Benylin pediatric syrup after routine testing revealed elevated levels of diethylene glycol, a concerning contaminant.
Although diethylene glycol and its counterpart, ethylene glycol, have been associated with the deaths of over 300 children across Cameroon, Gambia, Indonesia, and Uzbekistan since 2022, there is currently no evidence linking these incidents to the recent recalls.
WHO warns against contaminated syrup
The WHO, known for issuing global medical product alerts to prompt vigilance among national authorities, is expected to take similar action pending confirmation of specific details from involved parties.
- The batch of Benylin syrup under recall was produced by Johnson & Johnson in South Africa in May 2021.
- However, following a spin-off from J&J last year, the brand is now owned by Kenvue (KVUE.N).
- Kenvue, in response to inquiries, stated that it had conducted tests on the recalled batch and had not detected either diethylene or ethylene glycol.
In a statement, Kenvue emphasized its cooperation with health authorities and the WHO, expressing willingness to collaborate with Nigeria’s National Agency for Food and Drug Administration and Control (NAFDAC) to verify test results and ensure product authenticity.
Also, while diethylene glycol poses significant health risks, including acute kidney failure when ingested, no adverse effects have been reported in the current incident.
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Investigations into the contamination of the syrup in Nigeria are underway, with the WHO collaborating with both the manufacturer and South Africa’s regulatory authority. Kenvue has asserted its adherence to rigorous testing protocols for ingredients before manufacturing.
Concerns about counterfeit products are being considered as part of ongoing investigations. The WHO recently issued an alert regarding contaminated cough syrup ingredients discovered in Pakistan, emphasizing the importance of caution among manufacturers.
Propylene glycol, which is not an ingredient in Benylin pediatric syrup, was the focus of the WHO’s recent alert.
