Curium US, LLC recalls Kit for the Preparation of Technetium Tc 99m Sestamibi Injection, Each Kit contains: 30 sterile and non-pyrogenic reacti
Recalled January 1, 2025 · FDA recall D-0164-2025 · Curium US
Hazard
Lack of Assurance of Sterility; Improper crimps on vials impacting the integrity of the product · FDA Class II
Units
5,160 vials (172 kits 30 vials/kit)
Sold at
Nationwide USA and Canada.
Description
Lack of Assurance of Sterility; Improper crimps on vials impacting the integrity of the product
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
Manufacturer(s)
Curium US, LLC
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →