FDAHealthNovember 22, 2024
Jubilant Draximage Inc., dba Jubilant Radiopharma — Kit for the Preparation of Technetium Tc 99m Sulfur Colloid Injection, 10 mL Multi-Dose Reaction Vial, 5 vial Box, Rx Only, Manufactured for: Jubila
⚠️ Failed Stability Specifications
Is this relevant to me?
- Geography
- Nationwide
- Source agency
- FDA
- Category
- Health
- Published
- November 22, 2024
US Nationwide.
What's affected?
- Product
- Kit for the Preparation of Technetium Tc 99m Sulfur Colloid Injection, 10 mL Multi-Dose Reaction Vial, 5 vial Box, Rx Only, Manufactured for: Jubilant Draximage Inc., dba Jubilant Radiopharma, Kirkland , Quebec, H9H, 4J$, Canada, NDC# 65174-179-05.
- Lot code
- C2300070
Additional details
LOT C2300070 and C2300070E;Exp. May 31, 2025
What should I do?
Recommended action
Class II recall. Voluntary: Firm initiated Quantity affected: 5209 kits.
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