WHO Alert on Falsified Dow Propylene glycol

WHO has issued an alert on falsified Propylene glycol bearing name of Dow detected in Pakistan. Authentic Dow USP/EP propylene glycol is a Pharmaceutical raw material (excipient) adhering to the standards of the United States and European Pharmacopoeias (USP/EP) for medicinal use. Dow has confirmed that the raw material identified in WHO alert is falsified and were not manufactured or supplied by DOW.

The falsified propylene glycol was detected in Pakistan by DRAP (Drug Regulatory Authority of Pakistan). Following an alert by WHO on contaminated syrup and suspension medicines (WHO Medical Product Alert N°8/2023), the DRAP investigated and identified the suspect drums of Propylene Glycol. Analysis of samples from the drums showed unacceptable levels of ethylene glycol contamination ranging from 0.76% to 100%.

These propylene glycol appear to have been deliberately and fraudulently mislabelled. Manufacturers of oral liquid medicines may have unknowingly purchased these contaminated raw materials and their drug products are at risk of contamination with ethylene glycol (EG). WHO advises Manufacturers of medicines to ensure that raw materials are acquired only from qualified and approved suppliers and also advises to test each batch of incoming raw materials for ethylene glycol and diethylene glycol before using as excipients in the production of liquid medicines.

• WHO Medical Product Alert N°1/2024: Falsified (contaminated) USP/EP PROPYLENE GLYCOL
• Medical Product Alert N°1/2024 – Annex 1