Diagnostic drug kit recalled due to sterility concerns and vial integrity issues
Curium US is recalling Technetium TC 99m Sestamibi diagnostic kits (Lot 092-24006) due to improper vial crimps that could compromise sterility assurance. The recall affects approximately 5,160 vials distributed nationwide.
The agency’s classification
FDA (Drugs): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: This is an FDA Class II pharmaceutical recall with sterility and container integrity concerns but no reported illnesses or injuries. Per the rubric, risk-of-harm products where injury has not yet been reported score at level 3 (High).
Plain-English summary
Curium US, LLC is recalling Technetium TC 99m Sestamibi preparation kits (Lot 092-24006) distributed nationwide in the USA and Canada. The recall affects approximately 5,160 vials across 172 kits.
The kits are being recalled because improper crimps on the reaction vials compromise product integrity and the assurance of sterility. Defective container closure could lead to loss of product sterility if the vials become contaminated.
The product is used in diagnostic imaging procedures and is distributed as prescription-only drug to healthcare facilities. Healthcare providers with affected kits should contact Curium US immediately with the lot number for further guidance.
The recalled product
- Product
- TECHNETIUM TC 99M SESTAMIBI (TECHNETIUM TC 99M SESTAMIBI)
- Brand
- TECHNETIUM TC 99M SESTAMIBI
- Manufacturer
- Curium US, LLC
- Category
- Drug — Diagnostic Imaging Kit
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (3)
- Lot 092-24006
- Catalog # N092D0
- Exp 06/15/2026
Distribution
Distributed nationwide across the United States.
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