WhichRecall
Class IIReported 2025-01-01

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

Recalled by Curium US, LLC

Reason for Recall

Lack of Assurance of Sterility; Improper crimps on vials impacting the integrity of the product

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Recall Number
D-0164-2025
Classification
Class II
Status
Terminated
Category
drug
Initiated
2024-11-26
Reported
2025-01-01
Distribution
Nationwide USA and Canada.
Code Info
Lot 092-24006, Catalog # N092D0, Exp 06/15/2026
Source: openFDA enforcement report. WhichRecall is not affiliated with the FDA. See our disclaimer.
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