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$, Canada, NDC# 65174-179-05.
FDA recall notice · announced January 15, 2025 · Jubilant Draximage Inc., Dba Jubilant Radiopharma
Class II FDA/FSIS Class II: use may cause temporary or medically reversible adverse health consequences.
The product
Kit for the Preparation of Technetium Tc 99m Sulfur Colloid Injection, 10 mL Multi-Dose Reaction Vial, 5 vial Box, Rx Only, Manufactured for: Jubilant Draximage Inc., dba Jubilant Radiopharma, Kirkland , Quebec, H9H, 4J$, Canada, NDC# 65174-179-05.
Reason for recall
Failed Stability Specifications
Notes
Distribution: US Nationwide.
Lot/code information: LOT C2300070 and C2300070E;Exp. May 31, 2025
Quantity: 5209 kits
Status: Ongoing
Products in this recall event:
- 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, Kirklan (D-0191-2025)
Source: U.S. Food and Drug Administration public recall data. This page reports official records and is not legal, medical, or repair advice.