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.