Reported Jan 1, 2025 · Terminated
Kit for the Preparation of Technetium Tc 99m Sestamibi Injection, Each Kit contains: 30 sterile and non-pyrogenic…
Curium US, LLC
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Curium US, LLC · 2703 Wagner Pl · Maryland Heights, MO · 63043-3421
Is this the product you have?
- Kit for the Preparation of Technetium Tc 99m Sestamibi Injection
- Each Kit contains30 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 byCurium US LLC, Maryland Heights, MO 63043, 69945-092-40
- Lot codes and dates
Lot 092-24006Catalog # N092D0Exp 06/15/2026
- Amount recalled
- 5,160 vials (172 kits 30 vials/kit)
Where it was sold
- Nationwide
Why it was recalled
Lack of Assurance of Sterility; Improper crimps on vials impacting the integrity of the product
This product could cause temporary or reversible health problems — stop using it.
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