Radioactive Diagnostic Agent
Where is Rubidium Cation Rb-82 made?
2 companies sell it under their own name. Their labels name 3 factories in Canada and the United States.
Canada 2United States 1
Companies and their factories
| Company on the label | Factory | Where | Last FDA inspection |
|---|---|---|---|
| Bracco Diagnostics Inc. CardioGen-82150 mCi · NDC 0270-0091 | BWXT Medical Ltd.Makes the active ingredient | Vancouver, Canada | Problems found, fixed voluntarilyFeb 2024 |
| GE Healthcare Inc. (Medi-Physics, Inc. dba GE Healthcare)Makes it, tests it, packages it and labels it | Arlington Heights, IL, United States | No problems foundSep 2025 | |
| Jubilant DraxImage Inc., dba Jubilant Radiopharma Ruby-Fill100 mCi · NDC 65174-021 | Jubilant DraxImage Inc., dba Jubilant RadiopharmaMakes it | Kirkland, Canada | Problems found, fixed voluntarilyApr 2024 |
Recalls
- Jun 1, 2012 · Class II · Bracco Diagnostics Inc
GMP deviation; Sr-82 levels exceeded alert limit specification
Class I recalls are the most serious; Class III the least. A recall covers specific lots, listed on each recall.