Ultratag Rbc Recall
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Questions & Answers
Side Effects & Adverse Reactions
None known.
Legal Issues
There is currently no legal information available for this drug.
FDA Safety Alerts
There are currently no FDA safety alerts available for this drug.
Manufacturer Warnings
There is currently no manufacturer warning information available for this drug.
FDA Labeling Changes
There are currently no FDA labeling changes available for this drug.
Uses
Technetium Tc 99m-labeled red blood cells are used for blood pool imaging, including cardiac first pass and gated equilibrium imaging and for detection of sites of gastrointestinal bleeding.
History
There is currently no drug history available for this drug.
Other Information
UltraTag™ RBC (kit for the preparation of technetium Tc 99m-labeled red blood cells) is a sterile, nonpyrogenic, diagnostic kit for the in vitro preparation of technetium Tc 99m-labeled red blood cells.
Each kit consists of three separate nonradioactive components:
1. A 10 milliliter reaction vial containing:
Stannous Chloride, Dihydrate (SnCl2•2H2O) – 50 ug minimum
Stannous Chloride, Dihydrate (SnCl2•2H2O) – 96 ug theoretical
Tin Chloride (Stannous and Stannic), Dihydrate (as SnCl2•2H2O) – 105 ug maximum
Sodium Citrate, Dihydrate – 3.67 mg
Dextrose, Anhydrous – 5.50 mg
Prior to lyophilization, the pH is adjusted to 7.1 to 7.2 with sodium hydroxide. The contents of the vial are lyophilized and stored under argon.
2. Syringe I contains:
Sodium Hypochlorite – 0.6 mg in Sterile Water for Injection
The total volume of this syringe is 0.6 mL. Sodium hydroxide may have been added for pH adjustment. The pH of this solution is 11 to 13. The syringe must be protected from light to prevent degradation of the light-sensitive sodium hypochlorite.
3. Syringe II contains:
Citric Acid, Monohydrate – 8.7 mg
Sodium Citrate, Dihydrate – 32.5 mg
Dextrose, Anhydrous – 12.0 mg in Sterile Water for Injection
The total volume of this syringe is 1.0 mL. The pH range of this solution is adjusted to 4.5 to 5.5 with sodium citrate or citric acid.
Sources