Class IITerminated

Kit for the Preparation of Technetium Tc 99m Sestamibi Injection recall

FDA recall D-0164-2025 · initiated Nov 26, 2024

May cause temporary or medically reversible harm; low probability of serious harm.

Why it was recalled

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

Details

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
Recalling company: Curium
Classification: Class II
Status: Terminated
Type: Voluntary: Firm initiated
Distribution: Nationwide USA and Canada.
Initiated: Nov 26, 2024
FDA report date: Jan 1, 2025

What to do.If you have a recalled product, don't throw away questions — check the FDA notice for the affected lot numbers and expiration dates, and ask your pharmacist or doctor before stopping a prescribed medicine. This page reproduces public FDA data and is not medical advice.

Source: openFDA Drug Enforcement record D-0164-2025 ↗

← All drug recalls