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WHO likely to issue wider alert on contaminated J&J cough syrup
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WHO likely to issue wider alert on contaminated J&J cough syrup
Apr 19, 2024 7:37 AM

LONDON, April 19 (Reuters) - The World Health

Organization is likely to issue a wider warning about

contaminated Johnson and Johnson ( JNJ )-made children's cough

syrup found in Nigeria last week, it said in an email.

Nigeria's regulator recalled a batch of Benylin paediatric

syrup last Wednesday, having found a high level of diethylene

glycol in the product during routine testing.

The contaminant, alongside another closely related toxin,

ethylene glycol, has been linked to the deaths of more than 300

children in Cameroon, Gambia, Indonesia and Uzbekistan since

2022, though there is no evidence that these incidents are

linked with the latest 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 recalled batch of Benylin syrup was made by J&J in South

Africa in May 2021, although Kenvue ( KVUE ) now owns the brand

after a spin-off from J&J last year.

J&J has referred requests for comment to Kenvue ( KVUE ). In an

emailed statement on Friday, Kenvue ( KVUE ) said it had carried out

tests on the batch recalled by Nigeria and had not detected

either diethylene or ethylene glycol.

"We continue to work closely with health authorities and the

WHO and are engaging with NAFDAC to understand their test

results, including verifying the authenticity of the sampled

product, the testing methodology used, and results reported by

the agency," the statement added.

Since Nigeria's recall, five other African countries have

also pulled the product from shelves - Kenya, Rwanda, 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 the

Benylin paediatric syrup, and had information on the source of

the ingredients used. Kenvue ( KVUE ) has previously said it tested its

ingredients before manufacture.

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 that appeared to have been falsely labelled as Dow

Chemical products.

It was the first alert the WHO has sent on excipients -

elements of a medicine other than the active pharmaceutical

ingredient - rather than finished products, the agency confirmed

on Friday.

The batches of propylene glycol were contaminated with

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.

Propylene glycol is not an ingredient in Benylin paediatric

syrup, a Kenvue ( KVUE ) spokesperson said on Friday.

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