This WHO Alert refers to falsified DOW USP/EP PROPYLENE GLYCOL detected in Pakistan.

Authentic DOW USP/EP PROPYLENE GLYCOL is a raw material (excipient) utilized in pharmaceutical and other manufacturing processes, adhering to the standards of the United States and European Pharmacopoeias (USP/EP) for medicinal use.

WHO has previously published seven Alerts on contaminated oral liquid medicines. 

Following WHO Medical Product Alert N°8/2023 Product Alert N°8/2023 in December 2023, the Drug Regulatory Authority of Pakistan (DRAP) investigated potential contamination of oral liquid medicines. Suspect drums of PROPYLENE GLYCOL were identified by DRAP, and samples were tested by Pakistan’s Central Drugs Laboratory. The analyses revealed unacceptable levels of ethylene glycol contamination, ranging from 0.76% to 100%. Between January and March 2024, DRAP issued three Rapid Alerts regarding five contaminated batches of DOW USP/EP PROPYLENE GLYCOL.

DOW has confirmed that the raw materials detailed in the DRAP Alerts, and identified in this WHO Alert are falsified and were not manufactured or supplied by DOW. The quality and safety of these excipients therefore cannot be assured.

The PROPYLENE GLYCOL materials identified in this Alert are considered to have been deliberately and fraudulently mislabelled. They contain high levels of ethylene glycol, which if ingested can be toxic. These raw materials may have been distributed to other countries, including through informal or unregulated markets. Manufacturers of oral liquid medicines may have unknowingly purchased these contaminated raw materials, which may still be in their storage facilities.