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 Iohexol Injection monograph.
At the request of the Nomenclature, Safety, and Labeling Expert Committee, the Labeling statement is revised to include a warning regarding possible serious side effects of intrathecal administration of selected dose strengths.
In addition, the Packaging and Storage section is revised to make it consistent with FDA-approved package insert.
The Iohexol 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 email@example.com).