REGULATORY INTELLIGENCE·Recall
FDA Class II Recall: Jubilant Radiopharma's Technetium Tc 99m Sulfur Colloid Injection Fails Stability
Jubilant Draximage Inc., dba Jubilant Radiopharma, has initiated a Class II recall for 5,209 kits of Technetium Tc 99m Sulfur Colloid Injection due to failed stability specifications. This US nationwide recall, originating from their Kirkland, Canada facility, poses immediate supply chain disruption for diagnostic imaging centers, necessitating urgent procurement re-evaluation and robust quality assurance from all radiopharmaceutical suppliers.
90-Day Activity
Jubilant Draximage
MKMeera Krishnan· Senior Regulatory Intelligence Analyst2025-01-15