LONDON, (Reuters) – The World Health Organization is likely to issue a wider warning about contaminated Johnson and Johnson-made JNJ.N children’s cough syrup found in Nigeria last week, it said in an email.
Nigeria’s regulator recalled a batch of Benylin syrup last Wednesday, having found a high level of diethylene glycol in the product during routine testing.
The contaminant, alongside another closely related toxin, has been linked to the deaths of more than 300 children in Gambia, Uzbekistan, Indonesia and Cameroon since 2022, though there is no evidence that these incidents are linked with the new recalls.
The U.N. health body said it puts out global medical product alerts to “encourage diligence” by national authorities and was likely to do so in this instance, “subject to confirmation of certain details from parties”.
The batch of Benylin syrup recalled was made by J&J in South Africa in May 2021, although Kenvue KVUE.N now owns the brand after a spin-off from J&J last year.
J&J has referred requests for comment to Kenvue. Kenvue was not immediately available for comment, but said this week it was conducting its own assessment and working with health authorities to determine a course of action.
Since Nigeria’s recall, five other African countries have also pulled the product from shelves – Rwanda, Kenya, Tanzania, Zimbabwe and South Africa, where the drug was made.
South Africa’s regulator has also recalled another batch of the syrup, which is used to treat coughs, hay fever and other allergic reactions in children.
Diethylene glycol is toxic to humans when consumed and can result in acute kidney failure, although there have been no reports of harm in the latest incident.
RAW MATERIALS
In the 2022 cases, the contamination in the syrups came from the raw materials used by manufacturers in India and Indonesia.
The WHO said it was collaborating with both the manufacturer and regulatory authority in South Africa to investigate this for the Benylin paediatric syrup, and had information on the source of the ingredients used. It did not disclose the source.
According to the WHO, Kenvue said it had tested the raw materials used in the syrup before manufacture, and “no issues of concern were noted”.
The agency said the possibility that the syrup was counterfeit was also “under consideration as part of investigations”.
Earlier this week the WHO sent out a separate alert on five batches of contaminated cough syrup ingredients found in Pakistan, which appear to have been falsely labelled as Dow Chemical products.
It was the first ever alert sent by the WHO on excipients – elements of a medicine other than the active pharmaceutical ingredient – rather than finished products, the agency confirmed on Friday.
The batches were contaminated with the related toxin, ethylene glycol.
“It was critical for WHO to also alert manufacturers that may have been procuring this material to exercise more caution,” a WHO spokesperson said by email.