Status
Completed
Drug Enforcement D-0164-2025
Lack of Assurance of Sterility; Improper crimps on vials impacting the integrity of the product
Classification
Class II
Report Date
January 1, 2025
Termination Date
—
Product Information
- Product 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
- Product quantity
- 5,160 vials (172 kits 30 vials/kit)
- Reason for recall
- Lack of Assurance of Sterility; Improper crimps on vials impacting the integrity of the product
- Recall initiation reason
- —
- Initial firm notification
- Letter
- Distribution pattern
- Nationwide USA and Canada.
Location & Firm
- Recalling firm
- Curium US, LLC
- Address
-
2703 Wagner Pl
United States - Voluntary / Mandated
- Voluntary: Firm initiated
- Status date
- —
Codes & Dates
- Recall number
- D-0164-2025
- Event ID
- 95839
- Recall initiation date
- November 26, 2024
- Center classification date
- December 26, 2024
- Code info
- Lot 092-24006, Catalog # N092D0, Exp 06/15/2026
- More code info
- —