Drug 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.
D-0191-2025
Product summary
- Event
- Event 95836
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 5209 kits
- Official record key
drug-enforcement:D-0191-2025
Official wording
Reason: Failed Stability Specifications
Code information: LOT C2300070 and C2300070E;Exp. May 31, 2025
Distribution pattern: US Nationwide.
Derived failure modes
-
Potency or specification failure
Failed Stability Specifications