Kit for the Preparation of Technetium Tc 99m Sestamibi Injection — Class II drug recall D-0164-2025
Terminated recall by Curium US, LLC, reported 2025-01-01, distributed nationwide. Lack of Assurance of Sterility; Improper crimps on vials impacting the integrity of the product
| Recall number | D-0164-2025 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Curium US, LLC, Maryland Heights, MO, United States |
| Recall initiated | 2024-11-26 |
| Classified | 2024-12-26 |
| Reported by FDA | 2025-01-01 |
| Terminated | 2025-10-10 |
| Distributed | Nationwide (US) |
| Countries outside the US | CA |
| Reason classes | sterility |
| NDC | 69945-0092, 69945-0092-20, 69945-0092-40 |
| Lot numbers | 092-24006 |
| Model numbers | N092D0 |
| Expiration dates | 2026-06-15 |
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
Reason for recall
Lack of Assurance of Sterility; Improper crimps on vials impacting the integrity of the product
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/D-0164-2025. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.