Recalls / Class II
Class IID-0164-2025
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
- Brand name
- Technetium Tc 99m Sestamibi
- Generic name
- Technetium Tc 99m Sestamibi
- Active ingredient
- Tetrakis(2-methoxyisobutylisocyanide)copper(i) Tetrafluoroborate
- Route
- Intravenous
- NDC
- 69945-092
- FDA application
- ANDA078098
- Affected lot / code info
- Lot 092-24006, Catalog # N092D0, Exp 06/15/2026
Why it was recalled
Lack of Assurance of Sterility; Improper crimps on vials impacting the integrity of the product
Recalling firm
- Firm
- Curium US, LLC
- Manufacturer
- Curium US LLC
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 2703 Wagner Pl, Maryland Heights, Missouri 63043-3421
Distribution
- Quantity
- 5,160 vials (172 kits 30 vials/kit)
- Distribution pattern
- Nationwide USA and Canada.
Timeline
- Recall initiated
- 2024-11-26
- FDA classified
- 2024-12-26
- Posted by FDA
- 2025-01-01
- Terminated
- 2025-10-10
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0164-2025. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.