TETRAKIS(2-METHOXYISOBUTYLISOCYANIDE)COPPER(I) TETRAFLUOROBORATE Recall D-0164-2025
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
TETRAKIS(2-METHOXYISOBUTYLISOCYANIDE)COPPER(I) TETRAFLUOROBORATE Recall D-0164-2025 Information
| Status | Ongoing |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | D-0164-2025 |
| Event ID | 95839 |
| Brand | TECHNETIUM TC 99M SESTAMIBI |
| Generic Name | TECHNETIUM TC 99M SESTAMIBI |
| Manufacturer | TECHNETIUM TC 99M SESTAMIBI |
| Original Package? | 1 |
| Active Substance | TETRAKIS(2-METHOXYISOBUTYLISOCYANIDE)COPPER(I) TETRAFLUOROBORATE |
| Drug Route | INTRAVENOUS |
| Distribution | Nationwide USA and Canada. |
| Quantity | 5,160 vials (172 kits 30 vials/kit) |
| Recall Reason | Lack of Assurance of Sterility; Improper crimps on vials impacting the integrity of the product |
| Drug Classification | Class II |
| Drug Code Info | 20250101 |
| Product NDC | 69945-092 |
| Recall Initiation Date | 20241126 |
| Report Date | 20250101 |
| Classification Date | 20241226 |
| Address | 2703 Wagner Pl Maryland Heights, MO 63043-3421 United States |
| Recalling Firm | Curium US, LLC |
| Initial Notification | Letter |
| Unique Ingredient Identifier | N6OU7HJ70P |
| Drug Application Number | ANDA078098 |
| Structured Product Labeling (SPL ID) | 4b00526c-6250-49d7-ba34-459ef89c8f43 |
| Structured Product Labeling (SPL Set ID) | 4110d0f4-3bcf-4688-a39f-42a81064c796 |
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