D-0191-2025 Class II Ongoing
FDA drug recall D-0191-2025 was initiated by Jubilant Draximage Inc., dba Jubilant Radiopharma on November 22, 2024 and is designated Class II. Reason for recall: Failed Stability Specifications The recall status is ongoing. Affected quantity: 5209 kits.
Recall Details
- Product Type
- Drugs
- Report Date
- January 15, 2025
- Initiation Date
- November 22, 2024
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 5209 kits
Product Description
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.
Reason for Recall
Failed Stability Specifications
Distribution Pattern
US Nationwide.
Code Information
LOT C2300070 and C2300070E;Exp. May 31, 2025