FDAFDA · Food and drugs·Recall number D-0164-2025
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
Published January 1, 2025 · Recall initiated: November 26, 2024
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Lack of Assurance of Sterility; Improper crimps on vials impacting the integrity of the product
What to do
Voluntary: Firm initiated · Letter
Recall details
- Brand
- TECHNETIUM TC 99M SESTAMIBI
- Manufacturer
- Curium US, LLC
- Distributor
- Nationwide USA and Canada.
- Lot
- Lot 092-24006, Catalog # N092D0, Exp 06/15/2026
- Risk classification
- Class II
- Area (FDA)
- drug
- Country
- United States
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