Why it was recalled
Lack of Assurance of Sterility; Improper crimps on vials impacting the integrity of the product
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
Lot numbers, UPCs & expiration codes
Lot 092-24006, Catalog # N092D0, Exp 06/15/2026
Where it was sold
Nationwide USA and Canada.
What to do if you have this product
- Compare the lot number and expiration date on your package with the codes above.
- Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
- If you have symptoms you think are related, contact your doctor. In an emergency call 911.
- Report side effects to FDA MedWatch at 1-800-FDA-1088.
Recall details
- Recall number
- D-0164-2025
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Nov 26, 2024
- FDA report date
- Jan 1, 2025
- Quantity
- 5,160 vials (172 kits 30 vials/kit)
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Curium US, LLC
Original FDA data
Every field from FDA enforcement report D-0164-2025, exactly as published.
Show all FDA fields
- City
- Maryland Heights
- State
- MO
- Status
- Terminated
- Country
- United States
- Event ID
- 95839
- Address
- 2703 Wagner Pl
- Code information
- Lot 092-24006, Catalog # N092D0, Exp 06/15/2026
- Postal code
- 63043-3421
- Report date
- Jan 1, 2025
- Product type
- Drugs
- Recall number
- D-0164-2025
- Classification
- Class II
- Recalling firm
- Curium US, LLC
- Product quantity
- 5,160 vials (172 kits 30 vials/kit)
- Termination date
- Oct 10, 2025
- Reason for recall
- Lack of Assurance of Sterility; Improper crimps on vials impacting the integrity of the product
- Voluntary / mandated
- Voluntary: Firm initiated
- 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
- Distribution pattern
- Nationwide USA and Canada.
- Recall initiation date
- Nov 26, 2024
- Initial firm notification
- Letter
- Center classification date
- Dec 26, 2024