Class IIReported 2025-01-15

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.

Recalled by Jubilant Draximage Inc., dba Jubilant Radiopharma

Reason for Recall

Failed Stability Specifications

Recall Number

D-0191-2025

Classification

Class II

Status

Ongoing

Category

drug

Initiated

2024-11-22

Reported

2025-01-15

Distribution

US Nationwide.

Code Info

LOT C2300070 and C2300070E;Exp. May 31, 2025

Source: openFDA enforcement report. WhichRecall is not affiliated with the FDA. See our disclaimer.