American Society of Hirudotherapy

The heparin recall of 2008

Narrative review published in Perfusion (2012)

Last Updated: June 18, 2026Reviewed by: ASH Editorial Board
Research article — evidence reviewArticle reference
Evidence: Research reportSafety & Infection ControlClinical LiteratureHedlund KD et al. · Perfusion, 2013

Abstract

Heparin is one of the oldest drugs still in widespread clinical use. Its discovery in 1916 predates the establishment of the Food and Drug Administration. Since 1935, over 15,000 research papers have been published on the effects of heparin. Because the exact chemical formula of heparin is unknown, synthetic manufacturing has proven difficult. In 2008, a worldwide recall of heparin occurred. Scientists determined that a contaminant known as oversulfated chondroitin sulfate was responsible for the numerous deaths and adverse events. This contaminant was first traced to a chemical plant in Changzou, China. This article will review the discovery of heparin and the adulteration process that jeopardized the world's heparin supply.

Abstract sourced from PubMed (NCBI) for the cited record. See the original publication for the authoritative version.

Publication typeJournal Article
Indexed MeSH termsChinaChondroitin SulfatesDrug ContaminationDrug RecallsHeparinHumans

Summary

This review traces heparin's history and the 2008 worldwide recall, in which oversulfated chondroitin sulfate contamination, first traced to a chemical plant in Changzou, China, caused numerous deaths and adverse events.

Context

This article reviews the discovery of heparin and the 2008 worldwide recall triggered by a contaminant, oversulfated chondroitin sulfate, which was responsible for numerous deaths and adverse events and was traced to a chemical plant in China. It discusses the historical context of heparin, the difficulty of synthetic manufacturing due to its unknown exact chemical formula, and the adulteration process that jeopardized the global heparin supply. The abstract makes no mention of leeches, hirudotherapy, hirudin, or any link to leech-derived anticoagulants. The work is strictly focused on pharmaceutical heparin history and contamination.

Citation

Reference (Vancouver style)

Hedlund KD, Coyne DP, Sanford DM, Huddelson J. The heparin recall of 2008. Perfusion. 2013;28(1):61-65. doi:10.1177/0267659112462274. PMID: 23042900

Bibliographic details (authors, volume, pages, DOI) are taken from the PubMed record.

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