New and Important Safety Information as Requested by the FDA
Dear Valued RUBY-FILL User,
Please find here an important drug safety communication, as requested by the FDA, regarding the potential risk to high-level radiation exposure in some patients due to Sr-82 and Sr-85 breakthrough in the eluate when using an incorrect solution to elute a Rubidium Rb-82 generator and failure to follow the quality control testing procedures.
This letter is being provided to you to comply with FDA requirements and applies to all Rubidium-82 generator manufacturers.
As of this date, Jubilant DraxImage Inc. has received no direct notifications, adverse events or complaints regarding incorrect eluent usage with its RUBY-FILL product in the United States. We encourage you to share the contents of this safety communication with your colleagues or those who would benefit from the information.
Sincerely,
Norman LaFrance MD, ME, FACP, FACNP, FACNM
Chief Medical Officer, Senior Vice
President
Jubilant Pharma