Technetium Tc 99m Sestamibi Injection
FDA Recall NDC 69945-092
FDA Enforcement Report: View Recall Date, Reasons, and Safety Status
Active & Historical Enforcement Reports
The FDA has identified 1 recorded enforcement report(s) associated with Technetium Tc 99m Sestamibi (NDC 69945-092). A significant event, classified as Class II, was initiated on Nov 26, 2024 by Curium Us Llc. The reported reason for this action was: "Lack of Assurance of Sterility; Improper crimps on vials impacting the integrity of the product"
This specific recall has a current status of TERMINATED, indicating that the FDA considers the recall process finished or the product successfully recovered.
This specific recall has a current status of TERMINATED, indicating that the FDA considers the recall process finished or the product successfully recovered.
Reported Recall Events
November 2024 Class II Recall: Lack of Assurance of Sterility; Improper crimps on vials impacting the integrity of the product
Recall Number
Class II Terminated
Lack of Assurance of Sterility; Improper crimps on vials impacting the integrity of the product
Nov 26, 2024
Jan 01, 2025
5,160 vials (172 kits 30 vials/kit)
Recall Profile & Regulatory Data
Event ID
95839
Classification
Class II
Enforcement Status
Terminated
Recalling Firm
Curium US, LLC
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Nationwide USA and Canada.
Termination Date
Oct 10, 2025
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
Batch or Lot Expiration Information
Lot# Lot 092-24006, Catalog # N092D0, Exp 06/15/2026
Affected Packages Involved in this Recall
69945-092-20Product
69945-092-40Product
About FDA Recall Enforcement Reports
FDA recall data documents classified recall actions associated with a product. Most recalls are limited to specific lots, batches, or package configurations rather than every unit of a drug.
If a recall is listed for an NDC, review the affected lot information and package details carefully. Patients and healthcare professionals should confirm whether a specific product in hand matches the lot or package information before assuming it is affected.
