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Recall data is sourced from official U.S. government agencies (CPSC, FDA, NHTSA, USDA) and processed using AI to improve readability. This site is not affiliated with or endorsed by any government agency. Always refer to the original agency notice for authoritative information.

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Medium RiskFDA Drug
Medications & Supplements/Prescription Drugs

Jubilant Radiopharma Sulfur Colloid Injection Recalled for Stability Issues

Agency Publication Date: January 8, 2025
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Summary

Jubilant Radiopharma (Jubilant Draximage Inc.) is recalling 5,209 units of its Kit for the Preparation of Technetium Tc 99m Sulfur Colloid Injection. This prescription drug kit, which contains 10 mL multi-dose reaction vials, is being recalled because it failed to meet stability specifications. The recall specifically affects lot numbers C2300070 and C2300070E with an expiration date of May 31, 2025.

Risk

The drug failed to meet stability requirements during testing, which means the medication may not perform as expected during medical imaging procedures. This could potentially lead to inaccurate diagnostic results or other complications during treatment.

What You Should Do

  1. The recalled product is the Kit for the Preparation of Technetium Tc 99m Sulfur Colloid Injection (NDC 65174-179-05), packaged in 5-vial boxes containing 10 mL multi-dose reaction vials.
  2. Identify the affected product by looking for lot numbers C2300070 or C2300070E with an expiration date of May 31, 2025, printed on the packaging.
  3. Stop using the recalled product immediately.
  4. Contact Jubilant Draximage Inc. or your authorized distributor to arrange for the return of any remaining affected kits.
  5. Call the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA) if you have additional questions or concerns.

Your Remedy Options

๐Ÿ“‹Other Action
How to: Stop using the recalled product. Contact the manufacturer or your distributor to arrange return.

Affected Products

Product: Kit for the Preparation of Technetium Tc 99m Sulfur Colloid Injection
Variants: 10 mL Multi-Dose Reaction Vial, 5 vial Box, Rx Only
Lot Numbers:
C2300070 (Exp. May 31, 2025)
C2300070E (Exp. May 31, 2025)
NDC:
65174-179-05

Manufactured for Jubilant Draximage Inc., dba Jubilant Radiopharma.

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 95836
Status: Active
Manufacturer: Jubilant Draximage Inc., dba Jubilant Radiopharma
Sold By: Hospitals; Radiopharmacies; Medical centers; Wholesalers
Manufactured In: Canada
Units Affected: 5209 kits
Distributed To: Nationwide

Were You Affected by This Recall?

If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.

Find an Attorney

This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.

AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES ยท Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.