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$, Canada, NDC# 65174-179-05.
Reported: January 15, 2025 Initiated: November 22, 2024 #D-0191-2025
Product Description
Kit for the Preparation of Technetium Tc 99m Sulfur Colloid Injection, 10 mL Multi-Dose Reaction Vial, 5 vial Box, Rx Only, Manufactured for: Jubilant Draximage Inc., dba Jubilant Radiopharma, Kirkland , Quebec, H9H, 4J$, Canada, NDC# 65174-179-05.
Reason for Recall
Failed Stability Specifications
Details
- Recalling Firm
- Jubilant Draximage Inc., dba Jubilant Radiopharma
- Units Affected
- 5209 kits
- Distribution
- US Nationwide.
- Location
- Kirkland
Frequently Asked Questions
What product was recalled? ▼
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. Units affected: 5209 kits.
Why was this product recalled? ▼
Failed Stability Specifications
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on January 15, 2025. Severity: Moderate. Recall number: D-0191-2025.
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