November 2024 FDA Recall Technetium Tc 99m Sestamibi by Curium Us, Llc
D-0164-2025 - Lack of Assurance of Sterility; Improper crimps on vials impacting the integrity of the product

This Class II drug recall was voluntarily initiated by Curium Us, Llc on November 26, 2024 for the product Technetium Tc 99m Sestamibi. The FDA reported the reason for recall as lack of assurance of sterility; improper crimps on vials impacting the integrity of the product. The product was distributed Nationwide and the recall is currently terminated.

Recall Number: D-0164-2025

Reason for Recall
Lack of Assurance of Sterility; Improper crimps on vials impacting the integrity of the product
Initiated
11-26-2024
Reported
01-01-2025
Quantity
5,160 vials (172 kits 30 vials/kit)

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
95839
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Curium US, LLC
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide USA and Canada.
Termination Date About Termination Date
Date that FDA officially terminated the recall.
10-10-2025
Product Description About Product Description
Full technical description of the 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

Batch or Lot Expiration Information

Lot# Lot 092-24006, Catalog # N092D0, Exp 06/15/2026

Affected Packages Involved in this Recall

69945-092-20 Technetium Tc 99m Sestamibi
69945-092-40 Technetium Tc 99m Sestamibi