FDA recall D-0191-2025

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

Distribution

US Nationwide.

Key facts

Status

Ongoing

Initiation date

2024-11-22

Report date

2025-01-15

Voluntary/Mandated

Voluntary: Firm initiated

Location

Kirkland, Canada

Primary source

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