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Contaminated Heparin Found in 11 Countries

Contaminated heparin blood-thinning medication has been found in 11 countries, and the U.S. Food and Drug Administration (FDA) has banned shipments from one Chinese drug manufacturing facility after inspections revealed safety problems at the plant.

In addition to the United States, heparin containing the contaminant -- called oversulfated chondroitin sulfate -- has been found in Australia, Canada, China, Denmark, France, Germany, Italy, Japan, The Netherlands, and New Zealand, according to an FDA Announcement. On Monday, the FDA sent a warning letter to Changzhou SPL Company in China, notifying the company that an FDA inspection of its manufacturing facilities revealed "significant deviations" from acceptable U.S. health and safety standards, and prohibiting future U.S.-bound shipments from the plant until those safety problems are remedied. The Los Angeles Times reports that the contaminated medication has been linked to as many as 81 deaths.

• Countries with Contaminated Heparin (FDA)
• FDA Warning Letter to Changzhou SPL Company [PDF file]
• Contaminated Blood Thinner Heparin Called a Worldwide Problem (L.A. Times)
• More Heparin Blood-Thinner Meds Recalled (FindLaw's Common Law Blog)

Full post as published by FindLaw's Common Law on April 22, 2008 (boomark / email).