Reported Jan 15, 2025 · Ongoing

Kit for the Preparation of Technetium Tc 99m Sulfur Colloid Injection, 10 mL Multi-Dose Reaction Vial, 5 vial Box, Rx…

Jubilant Draximage Inc., dba Jubilant Radiopharma

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

What you should do

Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.

Firm contact: Jubilant Draximage Inc., dba Jubilant Radiopharma · 16751 Rte Transcanadienne · Kirkland · N/A

Is this the product you have?

  • Kit for the Preparation of Technetium Tc 99m Sulfur Colloid Injection, 10 mL Multi-Dose Reaction Vial, 5 vial Box, Rx Only
  • Manufactured forJubilant Draximage Inc., dba Jubilant Radiopharma, Kirkland , Quebec, H9H, 4J$, Canada, NDC# 65174-179-05
Lot codes and dates
    • LOT C2300070 and C2300070E
    • Exp. May 31
    • 2025
Amount recalled
5209 kits

Where it was sold

  • Nationwide

Why it was recalled

Failed Stability Specifications

This product could cause temporary or reversible health problems — stop using it.

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Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA drug enforcement) notice

Data as of Sep 19, 5:05 PM UTC

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