Kit for the Preparation of Technetium Tc 99m Sulfur Colloid Injection, 10 mL Multi-Dose Reaction ...
FDA Recall #D-0191-2025 — Class II — November 22, 2024
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
Recalling Firm
Jubilant Draximage Inc., dba Jubilant Radiopharma — Kirkland
Classification
Class II — May cause temporary or medically reversible adverse health consequences.
Product Type
Drugs
Product Quantity
5209 kits
Distribution
US Nationwide.
Code Information
LOT C2300070 and C2300070E;Exp. May 31, 2025
Status
Ongoing
Voluntary / Mandated
Voluntary: Firm initiated