Quick answers
- What is Kit for the preparation of technetium tc 99M albumin aggregated used for?
- The FDA-approved label (Draximage MAA, Jubilant DraxImage Inc, February 13, 2024) says: “DRAXIMAGE MAA, after radiolabeling with sodium pertechnetate Tc 99m, is indicated for: Lung scintigraphy as an adjunct in the evaluation of pulmonary perfusion in adults and pediatric patients. Peritoneovenous shunt scintigraphy as an aid in the evaluation of its patency in adult patients. DRAXIMAGE MAA, after radiolabeling with sodium pertechnetate Tc 99m, is a radioactive diagnostic agent indicated for …” 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 albumin aggregated 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 albumin aggregated?
- 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 albumin aggregated been recalled?
- FDA enforcement reports list 1 recall of products of this medicine; the newest started June 16, 2022 (Class II). A recall usually concerns specific lots, not every product.
- Who makes Kit for the preparation of technetium tc 99M albumin aggregated?
- 2 companies list prescription products of Kit for the preparation of technetium tc 99M albumin aggregated in the FDA NDC Directory, including Jubilant DraxImage Inc and Curium US LLC.
What Kit for the preparation of technetium tc 99M albumin aggregated is used for
Quoted from the “Indications and Usage” section of the FDA-approved label.
DRAXIMAGE MAA, after radiolabeling with sodium pertechnetate Tc 99m, is indicated for: Lung scintigraphy as an adjunct in the evaluation of pulmonary perfusion in adults and pediatric patients. Peritoneovenous shunt scintigraphy as an aid in the evaluation of its patency in adult patients. DRAXIMAGE MAA, after radiolabeling with sodium pertechnetate Tc 99m, is a radioactive diagnostic agent indicated for …
— FDA label: Draximage MAA, Jubilant DraxImage Inc, effective February 13, 2024. 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, for solution · Injection, powder, lyophilized, for suspension |
|---|---|
| Route | Intravenous · Intraperitoneal |
| Prescription products | 2 in the FDA NDC Directory |
| Brand names | Draximage MAA, Pulmotech MAA |
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.
- Jubilant DraxImage Inc1 product
- Curium US LLC1 product
FDA approval history
- BLA: Biologics License Application: how a biologic medicine (made from living cells) is approved.
| Application | Sponsor | Approved | Later changes approved |
|---|---|---|---|
| BLA017881 TECHNETIUM TC 99M ALBUMIN AGGREGATED KIT | Draximage | December 30, 1987 | 13, latest December 1, 2023 2023: Labeling · 2017: Manufacturing (CMC) · 2016: Manufacturing (CMC) |
| BLA210089 PULMOTECH MAA | Cis Bio Intl | March 20, 2020 | 1, latest August 25, 2023 2023: Labeling |
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.
-
June 16, 2022 · Class II · Terminated · D-1189-2022
Lack of Assurance of Sterility: Out-of-specification test results obtained for Endotoxin testing.
Draximage MAA (Kit for the preparation of Technnetium Tc 99m Albumin Aggregate) 2.5 mg per vial, 30 glass vials per carton, Rx Only, Manufactured for Jubilant Draximage Inc. Kirkland, Canada, NDC 65174-270-30. — Jubilant Draximage 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 | bbefaa05-1dc0-3ae7-7264-ce1eddf0da2b |
|---|---|
| FDA labels (SPL) | 2 |
| FDA applications | BLA017881, BLA210089 |
| Active ingredients (FDA) | ALBUMIN AGGREGATED |
Sources
- FDA-approved label on DailyMed (National Library of Medicine) — Draximage MAA, Jubilant DraxImage Inc, effective February 13, 2024; 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 →