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FDA says testing ordered for all imported heparin
Mar 15, 08 FDA ApprovalsU.S. regulators said on Friday they issued an alert ordering the detention of all imported supplies of products containing the blood-thinner heparin so they can be tested for possible contamination.
“We will be stopping all heparin products slated for import and assuring that manufacturers are testing them, or we will be testing them ourselves,” Dr. Janet Woodcock, director of the FDA’s Center for Drug Evaluation and Research, told reporters during a conference call.
Baxter International Inc recalled most of its U.S. supplies of heparin last month after reports of deaths and serious reactions.
FDA officials have identified a contaminant in some of drug’s active ingredient, which comes from a plant in China. They have not determined if the contamination caused the reactions.
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