Prescription medicine
Tetrakis copper tetrafluoroborate Brand names: Cardiolite, Kit, Technetium
Tetrakis copper tetrafluoroborate (Kit) is a prescription medicine. FDA's NDC Directory lists it from 1 generic labeler.
- Generic listed
Check it at the source: the tetrakis copper tetrafluoroborate FDA label on DailyMed (effective September 10, 2026); every tetrakis copper tetrafluoroborate label on DailyMed.
Highlights of the record
FDA label of September 10, 2026; NDC Directory, Drugs@FDA and Orange Book, October 8, 2026
Used for
From the label: indications and usageINDICATIONS AND USAGE CARDIOLITE® is a myocardial perfusion agent indicated for: detecting coronary artery disease by localizing myocardial ischemia (reversible defects) and infarction (non-reversible defects) evaluating myocardial function and developing information for use in patient management decisions Myocardial Imaging: CARDIOLITE ® Kit for the Preparation of Technetium Tc99m Sestamibi for Injection, is a myoca
Forms and strengths
- 1 mg/ml
Injection (powder) (lyophilized) for solution; injection.
On the market
- Generic approvals
- No generic approved
- Labelers listed (NDC)
- 3 of which 1 under generic applications, 2 under brand applications, repackagers included
Supply and safety
- Pharmacy cost (NADAC)
- Not in the survey
- Shortage (FDA)
- No current entry
- Recalls by its makers (FDA)
- 1 since 2024 0 Class I among all firms' recalls; latest November 26, 2024
- FAERS reports
- 648 through July 30, 2026
What is tetrakis copper tetrafluoroborate used for?
From the label: indications and usageINDICATIONS AND USAGE CARDIOLITE® is a myocardial perfusion agent indicated for: detecting coronary artery disease by localizing myocardial ischemia (reversible defects) and infarction (non-reversible defects) evaluating myocardial function and developing information for use in patient management decisions Myocardial Imaging: CARDIOLITE ® Kit for the Preparation of Technetium Tc99m Sestamibi for Injection, is a myocardial perfusion agent that is indicated for detecting coronary artery disease by localizing myocardial ischemia (reversible defects) and infarction (non-reversible defects), in evaluating myocardial function and developing information for use in patient management decisions. […]
Source: FDA drug label (Cardiolite), SHINE SPECT USA, LLC, effective September 10, 2026 (SPL set 773b6729-2a74-49e7-9215-ca70da3b854c), via openFDA; the full label on DailyMed
Is there a generic for tetrakis copper tetrafluoroborate (Kit)?
No generic tetrakis copper tetrafluoroborate is approved (Drugs@FDA, October 8, 2026).
FDA's NDC Directory lists tetrakis copper tetrafluoroborate from 1 labeler under a generic (ANDA) application and from 2 brand labelers. A listing means the company has registered the product for sale; it does not show that every pharmacy stocks it.
Source: Drugs@FDA, FDA NDC Directory and the Orange Book (openFDA bulk files, October 8, 2026)
Has tetrakis copper tetrafluoroborate been recalled?
The FDA's Enforcement Report lists 1 recall naming tetrakis copper tetrafluoroborate since 2024: 0 Class I (the most serious), 1 Class II, 0 Class III; 0 still ongoing. A recall names products and lots, not every product of the medicine.
| Started | Class | Company | Reason |
|---|---|---|---|
| November 26, 2024 | Class II | Curium US, LLC | Lack of Assurance of Sterility; Improper crimps on vials impacting the integrity of the product |
Source: FDA Enforcement Report (drug recalls) via openFDA, through October 8, 2026
What does the tetrakis copper tetrafluoroborate label say about other medicines?
The tetrakis copper tetrafluoroborate label names no other medicine on this site. The labels of 11 other medicines name tetrakis copper tetrafluoroborate. The sentences are the labels' own; a label lists what its studies and reports found, not every interaction.
Other labels that name tetrakis copper tetrafluoroborate
Check tetrakis copper tetrafluoroborate against other medicines
Source: FDA drug label (Cardiolite), SHINE SPECT USA, LLC, effective September 10, 2026 (SPL set 773b6729-2a74-49e7-9215-ca70da3b854c), via openFDA; the full label on DailyMed
What do FAERS reports show for tetrakis copper tetrafluoroborate?
The FDA Adverse Event Reporting System holds 648 reports that list tetrakis copper tetrafluoroborate among the medicines taken, through July 30, 2026, each a report of something that happened, not proof the medicine caused it; 22 are coded as a death and 66 as a hospital stay. Counts follow how widely a medicine is used and watched, and they are not a measure of how risky it is.
Reports received each year
The most reported reactions
Source: FDA Adverse Event Reporting System (FAERS) via openFDA, reports through July 30, 2026
What next?
- Tetrakis copper tetrafluoroborate side effects
- the label's list beside FAERS reports
- Check an interaction
- what two or more labels say about each other