← FDA ENFORCEMENT
D-0191-2025Class II

Jubilant Draximage Inc., dba Jubilant Radiopharma

Recalling firm
Jubilant Draximage Inc., dba Jubilant Radiopharma
Product type
Drug
Status
Ongoing
Report date
2025-01-15
Distribution
US Nationwide.
Product quantity
5209 kits
Initiated by
Voluntary: Firm initiated
SPEQ quality domain
Validation & Qualification
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.

Code / lot info

LOT C2300070 and C2300070E;Exp. May 31, 2025

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Data: U.S. FDA openFDA enforcement API. Recall details are as reported by the FDA. The quality-domain mapping and severity are a SPEQ editorial interpretation of the recall reason, not an official FDA classification.