Falsified Medical Product Alert N°4/2024

USP/EP Propylene Glycol (pharmaceutical excipient): falsified product alert

WHO issued this alert on falsified propylene glycol, a raw material used to make medicines, detected in Pakistan in August 2024. The Drug Regulatory Authority of Pakistan confirmed on 8 October 2024 that batch F8900L8PPD6 was contaminated with ethylene glycol at 0.7624% v/v. WHO said the materials may have been sold online and distributed to other countries. It follows Alert N°1/2024 on five earlier batches.^1,2

Health risk as statedWHO said the materials may be contaminated with unknown substances such as, but not limited to, diethylene glycol or ethylene glycol, and should be considered unsafe.

Issued: 10 October 2024
Issued by: World Health Organization
Name stated on packaging: Container labels bear the DOW name.
Genuine manufacturer's statement: WHO said DOW confirmed in September 2024 that the materials were not manufactured or supplied by DOW and that all three batch numbers on the labels are falsified.
Countries where detected: Pakistan

Batches named in the alert

F9600L7PPA4, F8900L8PPD6, SS8900B3PPD5

Advice as stated

Treat the materials as unsafe and do not use them in any product for human use. Manufacturers should buy raw materials only from qualified suppliers and test each batch for ethylene glycol and diethylene glycol.

Names printed on falsified products are not evidence that the named company made them. Where WHO or a regulator reports the genuine manufacturer's statement, it is shown.

Sources

World Health Organization, Medical Product Alert N°4/2024: Falsified USP/EP PROPYLENE GLYCOL (10 October 2024)
World Health Organization, Medical Product Alert N°4/2024: annex (PDF) (10 October 2024)