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FDAFDA · Food and drugs·Recall number D-0191-2025

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.

Published January 15, 2025 · Recall initiated: November 22, 2024

Status when published: Ongoing — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.

What's the hazard

Failed Stability Specifications

What to do

Voluntary: Firm initiated · Letter

Recall details

Manufacturer
Jubilant Draximage Inc., dba Jubilant Radiopharma
Distributor
US Nationwide.
Lot
LOT C2300070 and C2300070E;Exp. May 31, 2025
Risk classification
Class II
Area (FDA)
drug
Country
Canada

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