FDAHealthNovember 26, 2024
Curium US, LLC — 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 isonitril
⚠️ Lack of Assurance of Sterility; Improper crimps on vials impacting the integrity of the product
Is this relevant to me?
- Geography
- Nationwide
- Source agency
- FDA
- Category
- Health
- Published
- November 26, 2024
Nationwide USA and Canada.
What's affected?
- 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
- Lot code
- 092-24006
Additional details
Lot 092-24006, Catalog # N092D0, Exp 06/15/2026
What should I do?
Recommended action
Class II recall. Voluntary: Firm initiated Quantity affected: 5,160 vials (172 kits 30 vials/kit).
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