Kit for the Preparation of Technetium Tc 99m Sestamibi Injection recall
FDA recall D-0164-2025 · initiated Nov 26, 2024
Curium US, LLC recalled Kit for the Preparation of Technetium Tc 99m Sestamibi Injection in Nov 2024 — an FDA Class II recall (D-0164-2025) because Lack of Assurance of Sterility; Improper crimps on vials impacting the integrity of the product.
May cause temporary or medically reversible harm; low probability of serious harm.
Why it was recalled
Lack of Assurance of Sterility; Improper crimps on vials impacting the integrity of the product
Sterility could not be assured
The maker could not guarantee the product was sterile. That matters most for injections and eye products, where a contaminated dose reaches past the body's defences.
This is a manufacturing or quality failure, not a finding that the medicine is unsafe to take — across every recall we hold, none was issued for that reason. It does not mean the batch was harmless.
Is your product affected? Check the lot number
A recall covers only specific lots. Find the lot number and expiration date on your package and compare them to the affected codes below — if yours is not listed, it was not part of this recall.
Quantity recalled: 5,160 vials (172 kits 30 vials/kit)
Details
- 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 mg; Stannous Chloride Dihydrate - 0.D75 mg; L-Cysteine Hydrochloride Monohydrate - 1 mg; Sodium Citrate Dihydrate - 2.6 mg; Mannitol - 20 mg. The pH is adjusted to 5.6 to 5.7 with HCI or NaOH prior to lyophilization. Sealed under nitrogen. 30 Radioassay Information Labels with radiation warning symbol. 1 package insert, Rx only, Manufacture by: Curium US LLC, Maryland Heights, MO 63043, 69945-092-40
- Recalling company
- Curium
- Classification
- Class II
- Status
- Terminated
- Type
- Voluntary: Firm initiated
- Distribution
- Nationwide USA and Canada.
- Initiated
- Nov 26, 2024
- FDA report date
- Jan 1, 2025
Frequently asked
- Was Kit for the Preparation of Technetium Tc 99m Sestamibi Injection recalled?
- Curium US, LLC recalled Kit for the Preparation of Technetium Tc 99m Sestamibi Injection in Nov 2024 — an FDA Class II recall (D-0164-2025) because Lack of Assurance of Sterility; Improper crimps on vials impacting the integrity of the product. May cause temporary or medically reversible harm; low probability of serious harm.
- Why was Kit for the Preparation of Technetium Tc 99m Sestamibi Injection recalled?
- Per the FDA enforcement record, the reason for recall D-0164-2025 was: Lack of Assurance of Sterility; Improper crimps on vials impacting the integrity of the product
- Is a recalled Kit for the Preparation of Technetium Tc 99m Sestamibi Injection dangerous to take?
- An FDA recall removes specific lots from the market for a defined reason and does not by itself mean the medicine is unsafe for everyone — your specific lot may never have been affected. May cause temporary or medically reversible harm; low probability of serious harm. Check the FDA notice for the affected lot numbers and expiration dates, and ask your pharmacist or doctor before stopping a prescribed medicine. This reproduces public FDA data and is not medical advice.
- Which lots of Kit for the Preparation of Technetium Tc 99m Sestamibi Injection are affected?
- Distributed: Nationwide USA and Canada.. The recall covers these lots — Lot 092-24006, Catalog # N092D0, Exp 06/15/2026. Check the lot number and expiration date on your package against this list; if yours is not listed, it was not part of recall D-0164-2025.