FDA-Drug2025-01-15Class II

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.

Jubilant Draximage Inc., dba Jubilant Radiopharma
Hazard

Failed Stability Specifications

Sold states
US Nationwide.
Affected count
5209 kits
Manufactured in
16751 Rte Transcanadienne, Kirkland, Canada
Products
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.

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0191-2025

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