FDA Drug recall D-0191-2025
Kit for the Preparation of Technetium Tc 99m Sulfur Colloid Injection, 10 mL Multi-Dose Reaction Vial, 5 vial Box, Rx Only, Manufactured fo…
- FDA Drug
- Class II
- ongoing
- Published 2025-01-15
On 2025-01-15 the FDA classified a Class II recall of Kit for the Preparation of Technetium Tc 99m Sulfur Colloid Injection, 10 mL Multi-Dose Reaction Vial, 5 vial Box, Rx Only, Manufactured fo… by Jubilant Draximage, citing failed Stability Specifications.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-0191-2025 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2024-11-22 |
| Published | 2025-01-15 |
| Last updated | 2026-09-13 11:52 UTC |
| Company | Jubilant Draximage |
| Distribution | US |
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.
Reason
Failed Stability Specifications
Identifiers
| code_info | LOT C2300070 and C2300070E;Exp. May 31, 2025 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:52 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0191-2025%22
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