FDAClass IIJanuary 1, 2025

Kit for the Preparation of Technetium Tc 99m Sestamibi recall: Sterility Concern

Kit for the Preparation of Technetium Tc 99m Sestamibi Injection, Each Kit contains: 30 sterile and non-pyrogenic reaction vials each containing…

Why was Kit for the Preparation of Technetium Tc 99m Sestamibi recalled?

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

What should I do if I have this product?

Review the official FDA enforcement record for current instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

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

Product
Kit for the Preparation of Technetium Tc 99m Sestamibi Injection, Each Kit contains: 30 sterile and non-pyrogenic reaction vials each containing…
Recalling firm
Curium US, LLC
Quantity
5,160 vials (172 kits 30 vials/kit)
Distribution
Nationwide USA and Canada.
Recall date
January 1, 2025
Classification
Class II
Status
Terminated
Agency
FDA (drug)
Open FDA enforcement record Latest recalls