Radioactive Diagnostic Agent
Where is Florbetaben F-18 made?
1 company sell it under their own name. Their labels name 22 factories in the United States.
United States 22
Companies and their factories
| Company on the label | Factory | Where | Last FDA inspection |
|---|---|---|---|
| Lantheus Biosciences Ltd., a Lantheus company Neuraceq135 mCi per 1 mL · NDC 54828-001 | Biomedical Research Foundation of Northwest LouisianaMakes it | Shreveport, LA, United States | Not inspected on record |
| Jubilant DraxImage Inc., dba Jubilant RadiopharmaMakes it | Norcross, GA, United States | No problems foundNov 2015 | |
| Jubilant DraxImage Inc., dba Jubilant RadiopharmaMakes it | Mobile, AL, United States | Problems found, fixed voluntarilyMar 2026 | |
| N-Molecular Inc. dba SOFIEMakes it | Oakwood Village, OH, United States | No problems foundJun 2025 | |
| N-Molecular, Inc. dba SOFIEMakes it | Haverhill, MA, United States | Problems found, fixed voluntarilyNov 2024 | |
| Pharmalogic Cincinatti, LLCMakes it | Cincinnati, OH, United States | No problems foundOct 2025 | |
| Pharmalogic Colorado, LLCMakes it | Aurora, CO, United States | No problems foundNov 2021 | |
| Pharmalogic Los Angeles, LLCMakes it | Los Angeles, CA, United States | Problems found, fixed voluntarilyFeb 2026 | |
| Pharmalogic Puerto Rico, Inc.Makes it | San Juan, PR, United States | Problems found, fixed voluntarilyAug 2026 | |
| Pharmalogic Salt Lake City, LLCMakes it | Salt Lake City, UT, United States | Problems found, fixed voluntarilyFeb 2026 | |
| SOFIE Co.Makes it | Miami Lakes, FL, United States | Not inspected on record | |
| SOFIE Co. dba SOFIEMakes it | Sanford, FL, United States | Problems found, fixed voluntarilyJan 2024 | |
| SOFIE Co. dba SOFIEMakes it | Romeoville, IL, United States | Problems found, fixed voluntarilyJul 2024 | |
| SOFIE Co. dba SOFIEMakes it | Sterling, VA, United States | Problems found, fixed voluntarilyJul 2025 | |
| SOFIE Co. dba SOFIEMakes it | Totowa, NJ, United States | Problems found, fixed voluntarilyAug 2023 | |
| SOFIE Co. dba SOFIEMakes it | Kansas City, MO, United States | Problems found, fixed voluntarilySep 2025 | |
| SOFIE Co. dba SOFIEMakes it | Gilroy, CA, United States | Problems found, fixed voluntarilyAug 2025 | |
| SOFIE Co. dba SOFIEMakes it | Morgantown, WV, United States | Problems found, fixed voluntarilyAug 2025 | |
| SOFIE Co. dba SOFIEMakes it | Dallas, TX, United States | Problems found, fixed voluntarilyApr 2026 | |
| SOFIE Co. dba SOFIEMakes it | Houston, TX, United States | Problems found, fixed voluntarilyOct 2025 | |
| SOFIE Co. dba SOFIEMakes it | Somerset, NJ, United States | Problems found, fixed voluntarilyJan 2023 | |
| SOFIE Co. dba SOFIEMakes it | Decatur, IL, United States | Problems found, fixed voluntarilyJan 2026 |
Recalls
- Aug 22, 2023 · Class II · Sofie Co dba Sofie
Lack of Assurance of Sterility: out-of-specification test results observed for Filter Integrity Test (FIT).
Class I recalls are the most serious; Class III the least. A recall covers specific lots, listed on each recall.