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WHO warns of falsified cough syrup ingredients seized in Pakistan
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WHO warns of falsified cough syrup ingredients seized in Pakistan
Apr 15, 2024 12:21 PM

April 15 (Reuters) - The World Health Organization

issued an alert on Monday warning drugmakers of five

contaminated batches of propylene glycol, an ingredient used in

medicinal syrups, that appear to have been falsely labelled as

manufactured by Dow Chemical units in Asia and Europe.

The Drug Regulatory Authority of Pakistan (DRAP) issued

three alerts between January and March over high levels of

ethylene glycol (EG), an industrial solvent known to be toxic,

found in drums purportedly made by subsidiaries of Dow Chemical

in Thailand, Germany and Singapore.

DRAP sent suspect drums of propylene glycol, a sweet-tasting

alcohol used in over-the-counter medicines such as cough syrups,

for testing. The samples were found to have EG contamination of

0.76-100%, according to the WHO. International manufacturing

standards say only trace amounts of EG, below 0.1%, can be

considered safe.

Contaminated cough syrups made in India and Indonesia have

been linked to deaths of more than 300 children globally since

late 2022. The medicines were found to contain high levels of EG

and diethylene glycol, leading to acute kidney injury and death.

In the Indonesia case, authorities found that one supplier had

placed false Dow Thailand labels onto drums containing EG that

it sold to a distributor for pharmaceutical use.

Several of the batches seized by DRAP were labelled as

having been manufactured in 2023, the WHO said, months after the

agency issued a global alert calling on drugmakers to verify the

quality of their suppliers.

The WHO said Dow confirmed that the materials identified in

its Monday alert and found by DRAP were not manufactured or

supplied by the company.

"The propylene glycol materials identified in this alert are

considered to have been deliberately and fraudulently

mislabelled," the WHO said, noting batches may have been

distributed to other countries and still be in storage.

Dow did not immediately respond to a request for comment.

The WHO alert comes the same week regulators in Tanzania and

Rwanda joined Nigeria, Kenya and South Africa to recall batches

of Johnson & Johnson ( JNJ ) children's cough syrup after

Nigeria said it found high levels of diethylene glycol, an

industrial solvent known to be toxic.

The batch of Benylin Paediatric syrup recalled 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.

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