FDA Drug recall D-0164-2025
Kit for the Preparation of Technetium Tc 99m Sestamibi Injection, Each Kit contains: 30 sterile and non-pyrogenic reaction vials each conta…
- FDA Drug
- Class II
- terminated
- Published 2025-01-01
On 2025-01-01 the FDA classified a Class II recall of Kit for the Preparation of Technetium Tc 99m Sestamibi Injection, Each Kit contains: 30 sterile and non-pyrogenic reaction vials each conta… by Curium Us, citing lack of Assurance of Sterility; Improper crimps on vials impacting the integrity of the product.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-0164-2025 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2024-11-26 |
| Published | 2025-01-01 |
| Last updated | 2026-09-13 11:52 UTC |
| Company | Curium Us |
| Distribution | US |
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
Lack of Assurance of Sterility; Improper crimps on vials impacting the integrity of the product
Identifiers
| ndc | 69945-092-20 |
|---|---|
| ndc | 69945-092-40 |
| code_info | Lot 092-24006, Catalog # N092D0, Exp 06/15/2026 |
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:52 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0164-2025%22
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