Class II
Ongoing
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.
This recall is currently active, issued January 15, 2025. It was issued by Jubilant Draximage Inc., Dba Jubilant Radiopharma.
- Recall Initiated
- November 22, 2024
- Posted
- January 15, 2025
- Recall Number
- D-0191-2025
- Voluntary / Mandated
- Voluntary: Firm initiated
- Quantity
- 5209 kits
- Firm Location
- Kirkland, Canada
- Official Source
- View on FDA website ↗
Reason for Recall
Failed Stability Specifications
Distribution
US Nationwide.
Lot / Code Info
LOT C2300070 and C2300070E;Exp. May 31, 2025
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