Kit for the Preparation of Technetium Tc 99m Sestamibi Injection, Each Kit contains: 30 sterile a...
FDA Recall #D-0164-2025 — Class II — November 26, 2024
Product Description
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
Reason for Recall
Lack of Assurance of Sterility; Improper crimps on vials impacting the integrity of the product
Recalling Firm
Curium US, LLC — Maryland Heights, MO
Classification
Class II — May cause temporary or medically reversible adverse health consequences.
Product Type
Drugs
Product Quantity
5,160 vials (172 kits 30 vials/kit)
Distribution
Nationwide USA and Canada.
Code Information
Lot 092-24006, Catalog # N092D0, Exp 06/15/2026
Status
Terminated
Voluntary / Mandated
Voluntary: Firm initiated