Curium US, LLC: Drug Recall
Recall #D-0164-2025 · 11/26/2024
Recall Details
- Recall Number
- D-0164-2025
- Classification
- Class II
- Product Type
- Drug
- Recalling Firm
- Curium US, LLC
- Status
- Terminated
- Date Initiated
- 11/26/2024
- Location
- Maryland Heights, MO, United States
- Voluntary/Mandated
- Voluntary: Firm initiated
- 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
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.