There is a history of sporadic reports around the world of supplies of glycerol contaminated with diethylene glycol (DEG) resulting in mortality and serious morbidity in patients receiving contaminated products.
In late 2006, DEG-contaminated glycerol in cough syrup was the cause of about 50 deaths in Panama. DEG-contaminated glycerol in paracetamol syrup was also attributed to at least 80 deaths in a similar incident in Haiti in 1995-1996. Other incidents have been reported in Argentina, Bangladesh, India and Nigeria and attributed to the deaths of hundreds of children. DEG was also responsible for a poisoning incident resulting in the death of 107 people in the United States in 1937, following ingestion of contaminated sulphanilamide elixir.
These incidents were related to both accidental cross-contamination of glycerol with industrial grade materials and, in some cases, to intentional substitution.
Recent cases show the following similarities:
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Pharmaceutical manufacturers of products containing contaminated glycerol did not perform full identity testing or tests to determine DEG on the glycerol raw material;
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pharmaceutical manufacturers of contaminated products relied on certificates of analysis (COAs) provided by the supplier;
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the origin of glycerine was not apparent the COA. The COA provided with the glycerol raw material may have been a copy of the original on a distributor letterhead. The supply chain for glycerol was not readily known by the medicinal-product manufacturer because the glycerol may have been sold several times between its manufacture and the medicinal- product manufacturer.
