Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
Kit for the Preparation of Technetium Tc 99m Sestamibi Injection Recalled by Curium US, LLC Due to Lack of Assurance of Sterility; Improper crimps on...
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact Curium US, LLC directly.
Affected Products
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
Quantity: 5,160 vials (172 kits 30 vials/kit)
Why Was This Recalled?
Lack of Assurance of Sterility; Improper crimps on vials impacting the integrity of the product
Where Was This Sold?
This product was distributed nationwide across all 50 states.
About Curium US, LLC
Curium US, LLC has 1 total recall tracked by RecallDetector.
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Data sourced from the FDA (Drug). Last updated March 26, 2026. View original report