FDA Recalls Radiopharmaceutical Kit Due to Failed Stability Specifications
Jubilant Draximage is recalling 5,209 kits of Technetium Tc 99m Sulfur Colloid Injection that failed stability specifications. The affected lots (C2300070, C2300070E) were distributed nationwide.
- 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.
- Category
- Drug
- Distribution
- Distributed nationwide