Kit for the Preparation of Technetium Tc 99m Sulfur Colloid Injection — Class II drug recall D-0191-2025
Ongoing recall by Jubilant Draximage Inc., dba Jubilant Radiopharma, reported 2025-01-15, distributed nationwide. Failed Stability Specifications
| Recall number | D-0191-2025 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Jubilant Draximage Inc., dba Jubilant Radiopharma, Kirkland, Canada |
| Recall initiated | 2024-11-22 |
| Classified | 2025-01-08 |
| Reported by FDA | 2025-01-15 |
| Distributed | Nationwide (US) |
| Quantity | 5,209 kits |
| Reason classes | specification failure |
| NDC | 65174-0179-05 |
| Lot numbers | C2300070, C2300070E |
| Expiration dates | 2025-05-31 |
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 for recall
Failed Stability Specifications
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/D-0191-2025. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.