NDC 54828-001
Neuraceq 135 mCi per 1 mL injection, solution
On the label: Lantheus Biosciences Ltd., a Lantheus company.
Where it's made
| Factory | Where | Role | Last FDA inspection |
|---|---|---|---|
| Biomedical Research Foundation of Northwest Louisiana | Shreveport, LA, United States | Makes it | Not inspected on record |
| Jubilant DraxImage Inc., dba Jubilant Radiopharma | Norcross, GA, United States | Makes it | No problems foundNov 5, 2015 · 2 inspections |
| Jubilant DraxImage Inc., dba Jubilant Radiopharma | Mobile, AL, United States | Makes it | Problems found, fixed voluntarilyMar 23, 2026 · 3 inspections |
| N-Molecular Inc. dba SOFIE | Oakwood Village, OH, United States | Makes it | No problems foundJun 6, 2025 · 3 inspections |
| N-Molecular, Inc. dba SOFIE | Haverhill, MA, United States | Makes it | Problems found, fixed voluntarilyNov 20, 2024 · 5 inspections, 1 with FDA action |
| Pharmalogic Cincinatti, LLC | Cincinnati, OH, United States | Makes it | No problems foundOct 24, 2025 · 1 inspection |
| Pharmalogic Colorado, LLC | Aurora, CO, United States | Makes it | No problems foundNov 12, 2021 · 1 inspection |
| Pharmalogic Los Angeles, LLC | Los Angeles, CA, United States | Makes it | Problems found, fixed voluntarilyFeb 5, 2026 · 1 inspection |
| Pharmalogic Puerto Rico, Inc. | San Juan, PR, United States | Makes it | Problems found, fixed voluntarilyAug 21, 2026 · 4 inspections |
| Pharmalogic Salt Lake City, LLC | Salt Lake City, UT, United States | Makes it | Problems found, fixed voluntarilyFeb 24, 2026 · 1 inspection |
| SOFIE Co. | Miami Lakes, FL, United States | Makes it | Not inspected on record |
| SOFIE Co. dba SOFIE | Sanford, FL, United States | Makes it | Problems found, fixed voluntarilyJan 22, 2024 · 4 inspections, 2 with FDA action |
| SOFIE Co. dba SOFIE | Romeoville, IL, United States | Makes it | Problems found, fixed voluntarilyJul 12, 2024 · 4 inspections |
| SOFIE Co. dba SOFIE | Sterling, VA, United States | Makes it | Problems found, fixed voluntarilyJul 25, 2025 · 5 inspections |
| SOFIE Co. dba SOFIE | Totowa, NJ, United States | Makes it | Problems found, fixed voluntarilyAug 11, 2023 · 4 inspections |
| SOFIE Co. dba SOFIE | Kansas City, MO, United States | Makes it | Problems found, fixed voluntarilySep 3, 2025 · 4 inspections |
| SOFIE Co. dba SOFIE | Gilroy, CA, United States | Makes it | Problems found, fixed voluntarilyAug 7, 2025 · 4 inspections |
| SOFIE Co. dba SOFIE | Morgantown, WV, United States | Makes it | Problems found, fixed voluntarilyAug 28, 2025 · 4 inspections |
| SOFIE Co. dba SOFIE | Dallas, TX, United States | Makes it | Problems found, fixed voluntarilyApr 21, 2026 · 4 inspections |
| SOFIE Co. dba SOFIE | Houston, TX, United States | Makes it | Problems found, fixed voluntarilyOct 28, 2025 · 4 inspections |
| SOFIE Co. dba SOFIE | Somerset, NJ, United States | Makes it | Problems found, fixed voluntarilyJan 20, 2023 · 4 inspections |
| SOFIE Co. dba SOFIE | Decatur, IL, United States | Makes it | Problems found, fixed voluntarilyJan 15, 2026 · 4 inspections |
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).
Lots: Batch # FBBVA123082201, EOS: 22 Aug 2023/08:25, EXP: 22 Aug 2023/18:25
Class I recalls are the most serious; Class III the least. A recall covers specific lots, listed on each recall.
Product details
- Generic drug
- Florbetaben F-18: every company that makes it
- Form
- injection, solution, intravenous
- Strength
- 135 mCi per 1 mL
- Approval
- NDA NDA204677
- On the market since
- Mar 20, 2014
- Package NDCs
54828-001-3054828-001-50- Official label
- DailyMed (National Library of Medicine), updated Jul 24, 2026
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