Drug 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
D-0164-2025
Product summary
- Firm
- Curium US, LLC
- Event
- Event 95839
- Status
- Terminated
- Classification
- Class II
- Quantity
- 5,160 vials (172 kits 30 vials/kit)
- Official record key
drug-enforcement:D-0164-2025
Official wording
Reason: Lack of Assurance of Sterility; Improper crimps on vials impacting the integrity of the product
Code information: Lot 092-24006, Catalog # N092D0, Exp 06/15/2026
Distribution pattern: Nationwide USA and Canada.
Derived failure modes
-
Sterility assurance
Lack of Assurance of Sterility