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Drug FDA Class II Terminated Contamination / non-sterility

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

Curium US, LLC Published Jan 1, 2025

Risk level

Class II

May cause a temporary or reversible health problem; slight chance of serious harm.

Severity score 55/100

What should you do?

  • Check whether you have this product, using the lot codes, UPCs, and dates listed below.
  • Do not eat, serve, or sell the affected product.
  • Return it to the place of purchase for a refund, or throw it away in a sealed bag so people and animals can’t get to it.
  • Contact Curium US, LLC or your place of purchase with questions, and see the source record below for full details.
Reason for recall

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

Hazards

Lack of Sterility Assurance · primaryImproper Vial Crimps

Affected products (1)

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

TECHNETIUM TC 99M SESTAMIBI · 5,160 vials (172 kits 30 vials/kit)

NDC: 69945-092, 69945-092-20, 69945-092-40
Lot codes: 092-24006
Code info: Lot 092-24006, Catalog # N092D0, Exp 06/15/2026

Affected areas

Nationwide

Timeline

  1. Initiated
    Nov 26, 2024
  2. Published
    Jan 1, 2025
  3. Terminated
    Oct 10, 2025
Recall number
D-0164-2025
Agency
U.S. Food and Drug Administration
Country
US
Source data (openFDA JSON) About FDA enforcement reports

FDA records come from the openFDA drug enforcement-report dataset — the agency's full weekly enforcement list. Most entries are not issued as consumer press releases, so they won't appear on fda.gov/recalls or in a web search. The source record link above resolves this exact recall by its number.