Falsified Medical Product Alert N°1/2024
USP/EP Propylene Glycol (pharmaceutical excipient): falsified product alert
WHO issued this alert after the Drug Regulatory Authority of Pakistan identified suspect drums of propylene glycol following Alert N°8/2023. Pakistan's Central Drugs Laboratory found ethylene glycol contamination ranging from 0.76% to 100%. DRAP issued three rapid alerts between 11 January and 11 March 2024 covering five batches. WHO said the materials were deliberately and fraudulently mislabelled.1,2
- Issued
- 15 April 2024
- Issued by
- World Health Organization
- Name stated on packaging
- Drums labelled as DOW USP/EP Propylene Glycol.
- Genuine manufacturer's statement
- WHO said DOW confirmed the materials were not manufactured or supplied by DOW and that their quality and safety cannot be assured.
- Countries where detected
- Pakistan
Batches named in the alert
Listed in the annex to the WHO alert: check the annex linked in the sources
Advice as stated
Manufacturers should buy raw materials only from qualified suppliers and test each incoming batch for ethylene glycol and diethylene glycol, using gas chromatography where available. Do not distribute finished products made with the affected materials without further testing.
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°1/2024: Falsified (contaminated) USP/EP PROPYLENE GLYCOL (15 April 2024)
- World Health Organization, Medical Product Alert N°1/2024: annex (PDF) (15 April 2024)