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U.S. Department of Health and Human Services

Safety

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Heparin Sodium in 0.9 percent Sodium Chloride Injection in Excel

Detailed View: Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CDER)

 

January 2013

Summary View

WARNINGS

Heparin-induced Thrombocytopenia (HIT) (With or Without Thrombosis)
  • to include “thrombus formation on a prosthetic cardiac valve"