FDA Recall D-0191-2025

Jubilant Draximage Inc., dba Jubilant Radiopharma

Class II Ongoing 538 days on record

Moderate impact — Class II recall — temporary or medically reversible adverse health consequence possible; remote probability of serious adverse health consequence.

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.

Lot / code: LOT C2300070 and C2300070E;Exp. May 31, 2025

Quantity: 5209 kits

Reason for recall

Failed Stability Specifications

Recall record

Recall number: D-0191-2025
Classification: Class II
Status: Ongoing
Voluntary or mandated: Voluntary: Firm initiated
Firm notification: Letter
Distribution: US Nationwide.
Recall initiated: 2024-11-22
Classified by FDA Center: 2025-01-08
FDA published: 2025-01-15
Recalling firm: Jubilant Draximage Inc., dba Jubilant Radiopharma

Operational response

Class II recalls indicate possible temporary or reversible health consequences. Remove affected lots from active dispensing. Segregate inventory. Check the firm’s recall notification for guidance on patient outreach.

For the official FDA enforcement record, see FDA's Recall Search.

‹ All recalls