Kit for the Preparation of Technetium Tc 99m Sestamibi Injection recalled over sterility concerns

Recall date

November 26, 2024

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Official notice title

Curium US, LLC recalls Kit for the Preparation of Technetium Tc 99m Sestamibi Injection, Each Kit contains: 30 sterile and non-pyrogenic react…

Recall number

D-0164-2025

FDA classification

Class II

Brand / firm

Curium US, LLC

Sold / distributed

Nationwide USA and Canada.

Why it was recalled

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

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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