Quick answers
- What is TETRAKIS(2-METHOXYISOBUTYLISOCYANIDE)COPPER(I) tetrafluoroborate used for?
- The FDA-approved label (Cardiolite, Shine Spect Usa, LLC, September 10, 2026) says: “1. INDICATIONS 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 …” This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.
- Does TETRAKIS(2-METHOXYISOBUTYLISOCYANIDE)COPPER(I) tetrafluoroborate have a boxed warning?
- No. None of the 4 FDA labels we found for this medicine has a boxed warning.
- Is there a shortage of TETRAKIS(2-METHOXYISOBUTYLISOCYANIDE)COPPER(I) tetrafluoroborate?
- No current shortage is listed by the FDA for the products of this medicine (FDA data from October 30, 2026).
- Has TETRAKIS(2-METHOXYISOBUTYLISOCYANIDE)COPPER(I) tetrafluoroborate been recalled?
- FDA enforcement reports list 1 recall of products of this medicine; the newest started November 26, 2024 (Class II). A recall usually concerns specific lots, not every product.
- Who makes TETRAKIS(2-METHOXYISOBUTYLISOCYANIDE)COPPER(I) tetrafluoroborate?
- 3 companies list prescription products of TETRAKIS(2-METHOXYISOBUTYLISOCYANIDE)COPPER(I) tetrafluoroborate in the FDA NDC Directory, including Lantheus Medical Imaging, Inc., Shine Spect USA, LLC and Curium US LLC.
What TETRAKIS(2-METHOXYISOBUTYLISOCYANIDE)COPPER(I) tetrafluoroborate is used for
Quoted from the “Indications and Usage” section of the FDA-approved label.
1. INDICATIONS 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 …
— FDA label: Cardiolite, Shine Spect Usa, LLC, effective September 10, 2026. Read the full label on DailyMed →
The FDA has 4 labels for products of this medicine (different makers and forms); uses can differ between them. Check the label that comes with your own medicine.
This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.
Conditions named on the label
These condition names appear word for word in the label’s “Indications and Usage” text (matched with a reviewed table). Each page lists hospitals whose own websites name the condition.
Related medical specialties
Boxed warning
A boxed warning (“black box”) is the FDA’s strongest warning on a drug label, for serious or life-threatening risks.
The label quoted above has no boxed warning.
0 of 4 FDA labels for this medicine have a boxed warning.
Forms and how it is given
| Dosage forms | Injection, powder, lyophilized, for solution · Injection |
|---|---|
| Route | Intravenous |
| Prescription products | 4 in the FDA NDC Directory |
| Brand names | Cardiolite, Kit for the Preparation of Technetium TC99M Sestamibi |
Companies that list this medicine
Labelers in the FDA NDC Directory: the company named on the package (maker or distributor), with the number of prescription products.
- Lantheus Medical Imaging, Inc.2 products
- Shine Spect USA, LLC1 product
- Curium US LLC1 product
FDA approval history
- NDA: New Drug Application: how a new (usually brand-name) medicine is approved.
- ANDA: Abbreviated New Drug Application: how a generic version is approved.
| Application | Sponsor | Approved | Later changes approved |
|---|---|---|---|
| NDA019785 CARDIOLITE, MIRALUMA | Shine | December 21, 1990 | 17, latest December 4, 2019 2019: Labeling · 2008: Efficacy · 2002: Labeling |
Generic approvals (1)
- ANDA078098Curium · September 22, 2008
Shortage status
The FDA drug shortage list does not show these products.
Recalls
From FDA enforcement reports, matched by the product’s NDC code. A recall usually covers specific lots only: check the lot number on your package and ask your pharmacist. Do not stop a medicine on your own.
-
November 26, 2024 · Class II · Terminated · D-0164-2025
Lack of Assurance of Sterility; Improper crimps on vials impacting the integrity of the product
Kit for the Preparation of Technetium Tc 99m Sestamibi Injection, Each Kit contains: 30 sterile and non-pyrogenic reaction vials each containing Tetrakis (2-methoxy isobutyl isonitrile) Copper (I) tetratluoroborate - 1 m — Curium US, LLC
What do the recall classes mean?
Class I: The most serious type: there is a reasonable chance that using the product will cause serious health problems or death.
Class II: Using the product may cause temporary or medically reversible health problems, or the chance of serious problems is remote.
Class III: Using the product is not likely to cause health problems (for example a labeling or packaging issue).
Official identifiers
| SPL set ID of the quoted label | 773b6729-2a74-49e7-9215-ca70da3b854c |
|---|---|
| FDA labels (SPL) | 4 |
| FDA applications | NDA019785, 1 ANDA |
| Active ingredients (FDA) | TETRAKIS(2-METHOXYISOBUTYLISOCYANIDE)COPPER(I) TETRAFLUOROBORATE |
Sources
- FDA-approved label on DailyMed (National Library of Medicine) — Cardiolite, Shine Spect Usa, LLC, effective September 10, 2026; via openFDA, FDA data exported October 30, 2026, retrieved October 31, 2026
- NDC Directory (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
- Drugs@FDA (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
- Drug recall enforcement reports (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 27, 2026, retrieved October 31, 2026
- Drug shortages (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
openFDA data is provided by the FDA as is; it may be incomplete. Always rely on the label that comes with your medicine. FDA Enforcement Report search →