# FDA recall D-0191-2025

> **Jubilant Draximage Inc., dba Jubilant Radiopharma** · Class II · drug recall initiated 2024-11-22.

## 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

## Distribution

US Nationwide.

## Key facts

- **Recall number:** D-0191-2025
- **Recalling firm:** Jubilant Draximage Inc., dba Jubilant Radiopharma
- **Classification:** Class II
- **Product type:** drug
- **Status:** Ongoing
- **Initiation date:** 2024-11-22
- **Report date:** 2025-01-15

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Kirkland, Canada

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0191-2025

## Citation

> AI Analytics. FDA recall D-0191-2025. Retrieved 2026-07-20 from https://api.ai-analytics.org/recall/D-0191-2025. Source: US FDA. Licensed CC0.

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