Curium US LLC
NDC labeler code: 69945
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
- Technetium TC-99MUltra-Technekow V4, Technelite · 13 products
- Sodium iodide i 1232 products
- Xenon XE-1332 products
- Copper cu 64 dotatateDetectnet · 1 product
- Technescan tc 99M mertiatideTechnescan MAG3, Kit for the Preparation of Technetium TC99M Mertiatide · 1 product
- TETRAKIS(2-METHOXYISOBUTYLISOCYANIDE)COPPER(I) tetrafluoroborateCardiolite, Kit for the Preparation of Technetium TC99M Sestamibi · 1 product
- Thallous chloride, tl 2011 product
- Lutetium lu 177 dotatateBexlutry, Lutathera · 1 product
- Technetium tc 99M pyrophosphateTechnescan Pyp · 1 product
- Ioflupane I-123Datscan · 1 product
- Kit for the preparation of technetium tc 99M pentetateDraximage Dtpa · 1 product
- Gallium citrate GA-671 product
- Kit for the preparation of technetium tc 99M albumin aggregatedDraximage MAA, Pulmotech MAA · 1 product
- Technetium tc 99M oxidronateTechnescan Hdp · 1 product
FDA applications for these products
- NDA: New Drug Application: how a new (usually brand-name) medicine is approved.
- ANDA: Abbreviated New Drug Application: how a generic version is approved.
- BLA: Biologics License Application: how a biologic medicine (made from living cells) is approved.
The sponsor is the company that holds the FDA application; it can differ from the labeler.
Recall timeline
2024
-
November 26, 2024 · Class II · Terminated · D-0164-2025 · TETRAKIS(2-METHOXYISOBUTYLISOCYANIDE)COPPER(I) tetrafluoroborate
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
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
- Latest FDA drug recallsAll companies, newest first
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- All prescription drugs A to ZSearch by generic, brand or Spanish name
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