Quick answers
- What is Kit for the preparation of technetium tc 99M mebrofenin used for?
- The FDA-approved label (Choletec, Bracco Diagnostics Inc, November 29, 2025) says: “Technetium Tc 99m Mebrofenin is indicated as a hepatobiliary imaging agent.” This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.
- Does Kit for the preparation of technetium tc 99M mebrofenin have a boxed warning?
- No. None of the 2 FDA labels we found for this medicine has a boxed warning.
- Is there a shortage of Kit for the preparation of technetium tc 99M mebrofenin?
- No current shortage is listed by the FDA for the products of this medicine (FDA data from October 30, 2026).
- Has Kit for the preparation of technetium tc 99M mebrofenin been recalled?
- FDA enforcement reports list 2 recalls of products of this medicine; the newest started April 10, 2018 (Class II). A recall usually concerns specific lots, not every product.
- Who makes Kit for the preparation of technetium tc 99M mebrofenin?
- 2 companies list prescription products of Kit for the preparation of technetium tc 99M mebrofenin in the FDA NDC Directory, including Sun Pharmaceutical Industries, Inc. and Bracco Diagnostics Inc.
What Kit for the preparation of technetium tc 99M mebrofenin is used for
Quoted from the “Indications and Usage” section of the FDA-approved label.
Technetium Tc 99m Mebrofenin is indicated as a hepatobiliary imaging agent.
— FDA label: Choletec, Bracco Diagnostics Inc, effective November 29, 2025. Read the full label on DailyMed →
The FDA has 2 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.
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 2 FDA labels for this medicine have a boxed warning.
Forms and how it is given
| Dosage forms | Injection, powder, lyophilized, for solution |
|---|---|
| Route | Intravenous |
| Prescription products | 2 in the FDA NDC Directory |
| Brand names | Choletec |
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.
- Sun Pharmaceutical Industries, Inc.1 product
- Bracco Diagnostics Inc1 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 |
|---|---|---|---|
| NDA018963 CHOLETEC | Bracco | January 21, 1987 | 5, latest September 10, 2015 2015: Manufacturing (CMC) · 2007: Manufacturing (CMC) · 2002: Manufacturing (CMC) |
Generic approvals (1)
- ANDA078242Sun Pharm Inds Inc · January 29, 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.
-
April 10, 2018 · Class II · Terminated · D-0815-2018
Failed Stability Specifications
Kit for the Preparation of Technetium TC-99M Mebrofenin, 45 mg in 10 mL (5 count), NDC 45567-0455-1 and (30 count), NDC 45567-0455-2 . Manufactured by: Pharmalucence, Inc., Billerica, MA 01821. — Pharmalucence, Inc.
-
August 14, 2012 · Class III · Terminated · D-095-2013
Presence of Particulate Matter; potential for charcoal particulates
Choletec - Kit for the Preparation of Technetium Tc 99m Mebrofenin, 10 vials per box, Nonradioactive, Diagnostic Use, For Intravenous Use, Multidose, Rx Only, Manufactured for Bracco Diagnostics Inc. Princeton, NJ 08543, — Bracco Diagnostic Inc
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 | fd085485-998d-42a3-879a-b2d96cb8aed7 |
|---|---|
| FDA labels (SPL) | 2 |
| FDA applications | NDA018963, 1 ANDA |
| Active ingredients (FDA) | MEBROFENIN |
Sources
- FDA-approved label on DailyMed (National Library of Medicine) — Choletec, Bracco Diagnostics Inc, effective November 29, 2025; 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 →