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Baxter Recalls Rest of Heparin Products
Date:2/28/2008

f the steps it takes to remove impurities and its investigation of out-of-specification results. Issues related to waste material flow and deficiencies related to equipment," Rogers said.

Rogers noted that while the FDA was concerned about what it found in the Chinese plant, it was not prepared to make a connection between these observations and the adverse events associated with Baxter's heparin.

Inspection of the Chinese plant came after the FDA reported Feb. 19 that it had made a mistake and inspected the wrong Chinese plant, which had a similar name.

More information

For more on heparin, visit the U.S. National Library of Medicine .



SOURCES: Feb. 28, 2008, teleconference with Rear Admiral Sandra Kweder, M.D., deputy director, Office of New Drugs, Center for Drug Evaluation and Research; Michael Rogers, director, Division of Field Investigations, Office of Regulatory Affairs, U.S. Food and Drug Administration, Rockville, Md.


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