Jubilant Draximage Inc., dba Jubilant Radiopharma: Drug Recall

Recall #D-0191-2025 · 11/22/2024

Class II: Risk

Recall Details

Recall Number
D-0191-2025
Classification
Class II
Product Type
Drug
Recalling Firm
Jubilant Draximage Inc., dba Jubilant Radiopharma
Status
Ongoing
Date Initiated
11/22/2024
Location
Kirkland, Canada
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
5209 kits

Reason for Recall

Failed Stability Specifications

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.

Distribution Pattern

US Nationwide.

Data from FDA openFDA enforcement reports. This site is not affiliated with or endorsed by the FDA. Recall information may be updated by the FDA at any time.