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Iodixanol Injection

Type of Posting: Revision Bulletin

Posting Date: 26–Aug–2011

Official Date: 01–Sep–2011

Expert Committee: Monographs—Small Molecules 4

Reason for Revision: Safety, Compliance

In accordance with the Rules and Procedures of the 2010–2015 Council of Experts, the Monographs—Small Molecules 4 Expert Committee has revised the Iodixanol Injection monograph.

At the request of the Nomenclature, Safety, and Labeling Expert Committee, the Labeling statement is added to provide specific instructions for its use and routes of administration, and to indicate that it is not approved for intrathecal use.

In addition, the Packaging and Storage and Osmolality and Osmolarity sections are revised to make them consistent with FDA-approved specifications and package insert.

The Iodixanol Injection Revision Bulletin supersedes the currently official monograph. The Revision Bulletin will be incorporated in the First Supplement to USP 35–NF 30.

Should you have any questions, please contact Ravi Ravichandran, Ph.D. (301-816-8330 or rr@usp.org).