WHO alerts on seized falsified cough syrup ingredients in Pakistan.

The World Health Organization (WHO) issued a grave alert on Monday, cautioning drug manufacturers about five tainted batches of propylene glycol, a common ingredient in medicinal syrups. These batches were falsely labeled as being produced by Dow Chemical units in Asia and Europe. The Drug Regulatory Authority of Pakistan (DRAP) echoed this concern, issuing three alerts between January and March regarding high levels of ethylene glycol (EG) found in drums purportedly manufactured by Dow Chemical subsidiaries in Thailand, Germany, and Singapore.

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Following these alerts, DRAP sent samples of the suspect propylene glycol drums for testing, revealing EG contamination levels ranging from 0.76% to 100%. Such levels far exceed international safety standards, which permit only trace amounts of EG, below 0.1%. Shockingly, contaminated cough syrups originating from India and Indonesia have been associated with the deaths of over 300 children globally since late 2022. These medicines were found to contain elevated levels of EG and diethylene glycol, leading to acute kidney injury and fatalities.

In one instance in Indonesia, authorities discovered that a supplier had affixed false Dow Thailand labels onto drums containing EG, which were then sold to a pharmaceutical distributor. Strikingly, several of the tainted batches seized by DRAP were labeled as being manufactured in 2023, despite a previous global alert from the WHO urging drugmakers to verify supplier quality.

Dow Chemical confirmed that the materials identified in the WHO's alert and discovered by DRAP were not produced or supplied by the company. The WHO emphasized that these mislabeled propylene glycol materials were deliberately and fraudulently distributed, potentially reaching other countries and remaining in storage.

Meanwhile, regulators in Tanzania and Rwanda joined Nigeria, Kenya, and South Africa in recalling batches of Johnson & Johnson children's cough syrup due to high levels of diethylene glycol. Notably, a batch of Benylin Paediatric syrup, produced by J&J in South Africa in May 2021, was recalled, although Kenvue now owns the brand following a spin-off from J&J last year.