REGULATORY INTELLIGENCE·Recall
Curium US LLC Initiates Class II Recall of Technetium Tc 99m Sestamibi Due to Sterility Concerns
Curium US LLC has initiated a Class II recall (D-0164-2025) for 5,160 vials of Technetium Tc 99m Sestamibi Injection Kits, distributed nationwide across the USA and Canada. The recall stems from a critical lack of sterility assurance and improper vial crimps, directly impacting product integrity. This event necessitates immediate action from procurement and supply chain leaders to mitigate disruption and ensure patient safety.
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