Jubilant DraxImage Inc
NDC labeler code: 65174
What is a labeler?
The company whose name is on the package and in the FDA’s National Drug Code (NDC) Directory. It may make the medicine itself or sell medicine made by another company. The first part of every NDC code identifies the labeler.
Official FDA data only
Products, approvals and recalls come from the FDA (NDC Directory, Drugs@FDA, enforcement reports). Recalls are linked to this company by the NDC labeler code on the recalled product.
Questions about your medicine: ask your doctor or pharmacist. In an emergency, call 911.
Prescription medicines
- Kit for the preparation of technetium tc 99M albumin aggregatedDraximage MAA, Pulmotech MAA · 1 product
FDA applications for these products
- BLA: Biologics License Application: how a biologic medicine (made from living cells) is approved.
| Approved | Application | Medicine | Sponsor |
|---|---|---|---|
| December 30, 1987 | BLA017881 | Kit for the preparation of technetium tc 99M albumin aggregated TECHNETIUM TC 99M ALBUMIN AGGREGATED KIT | Draximage |
The sponsor is the company that holds the FDA application; it can differ from the labeler.
Recall timeline
2022
-
June 16, 2022 · Class II · Terminated · D-1189-2022 · Kit for the preparation of technetium tc 99M albumin aggregated
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.
2020
-
March 19, 2020 · Class II · Terminated · D-1062-2020 · Kit for the preparation of technetium tc 99M pentetate
Failed Stability Specifications
DRAXIMAGE DTPA (KIT FOR THE PREPARATION OF TECHNETIUM TC 99M PENTETATE INJECTION), 20 mg vial, Rx only, Manufactured for: Jubilant Draximage, Inc., Kirkland, Quebec, Canada, NDC 65174-288-05, 67175-288-30
2016
-
March 11, 2016 · Class III · Terminated · D-0812-2016 · Sodium iodide i 131
Labeling: Label Error on Declared Strength
SODIUM IODIDE I 131 CAPSULE, USP DIAGNOSTIC ORAL , Rx only, Manufactured by Jubilant DraxImage, Inc., Kirkland, QC, Canada, NDC 65174-461-05
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).
Next steps
- Find a pharmacy near youAsk which company made your medicine and whether it is recalled
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Sources
- 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