FDA Issues Alert Over Chinese Crospovidone

Law360, New York (October 22, 2010, 11:31 AM EDT) -- The U.S. Food and Drug Administration has found high levels of peroxide in one lot of the drug ingredient crospovidone made by China-based Tianjin Boai NKY International Ltd., the agency said.

FDA issued a warning Thursday to drug and dietary-supplement makers, compounding pharmacies and distributors of povidone analogs, asking them to monitor peroxide levels for any povidone analogs they receive.

Povidone is a synthetic polymer used as a dispersing and suspending agent, and its analogs include crospovidone and copovidone. Crospovidone is a common ingredient in drugs...
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