TECHNETIUM TC 99M SESTAMIBI
Wed Jan 01 2025
1 of 12
Summary
Lack of Assurance of Sterility; Improper crimps on vials impacting the integrity of the product
Product Description
| Drug | Manufacturer | Distribution Pattern | Number of Affected Units |
|---|---|---|---|
| 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 | Curium US LLC | Nationwide USA and Canada. | 5,160 vials (172 kits 30 vials/kit) |