Drug Enforcement D-0191-2025

Failed Stability Specifications

Status

Ongoing

Classification

Class II

Report Date

January 15, 2025

Termination Date

—

Product Information

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.
Product quantity
5209 kits
Reason for recall
Failed Stability Specifications
Recall initiation reason
—
Initial firm notification
Letter
Distribution pattern
US Nationwide.

Location & Firm

Recalling firm
Jubilant Draximage Inc., dba Jubilant Radiopharma
Address
16751 Rte Transcanadienne

Canada
Voluntary / Mandated
Voluntary: Firm initiated
Status date
—

Codes & Dates

Recall number
D-0191-2025
Event ID
95836
Recall initiation date
November 22, 2024
Center classification date
January 8, 2025
Code info
LOT C2300070 and C2300070E;Exp. May 31, 2025
More code info
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