Kit for the Preparation of Technetium Tc 99m Sestamibi Injection, Each Kit contains: 30 sterile and non-pyrogenic reacti
Summary
The FDA issued a Class II for Kit for the Preparation of Technetium Tc 99m Sestamibi Injection, Each Kit conta by Curium US, LLC. Reason: Lack of Assurance of Sterility; Improper crimps on vials impacting the integrity of the product.
Details
Source
Drug Recall
External ID
D-0164-2025
Action Date
2025-01-01
Status
Terminated
Category
drug
Product Description
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
Lot/Code Info: Lot 092-24006, Catalog # N092D0, Exp 06/15/2026
Quantity Affected: 5,160 vials (172 kits 30 vials/kit)
Reason for Recall
Lack of Assurance of Sterility; Improper crimps on vials impacting the integrity of the product
Distribution
Nationwide USA and Canada.
Type: Voluntary: Firm initiated
Recall Initiated: 2024-11-26
Company
Maryland Heights, MO
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 38 drug recalls issued in the same week, part of 267 drug-related FDA actions this month.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Curium US, LLC) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Curium US, LLC have FDA actions?
This is the only FDA action we have on record for Curium US, LLC in our database.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "D-0164-2025" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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