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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

Draximage MAA Recalled for Sterility Concerns

Agency Publication Date: July 8, 2022
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Summary

Jubilant Draximage Inc. has voluntarily recalled 519 cartons of Draximage MAA (Kit for the preparation of Technetium Tc 99m Albumin Aggregate) 2.5 mg per vial. The recall was issued because testing showed the product did not meet sterility standards for endotoxins. This prescription medication is used in medical imaging procedures and was distributed to retailers across the country.

Risk

A lack of assurance of sterility means the product may contain contaminants that could cause serious infections or inflammatory reactions in patients. No injuries or illnesses have been reported in connection with this recall.

What You Should Do

  1. This recall affects Draximage MAA (Kit for the preparation of Technetium Tc 99m Albumin Aggregate) 2.5 mg per vial, packaged in cartons of 30 glass vials.
  2. Check your inventory for Lot # 1H005 with an expiration date of November 30, 2023, and NDC 65174-270-30.
  3. Stop using the recalled product immediately.
  4. Contact the manufacturer, Jubilant Draximage Inc., or your distributor to arrange for the return of any remaining vials.
  5. Call the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA) for additional questions.

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: Draximage MAA (Kit for the preparation of Technetium Tc 99m Albumin Aggregate)
Variants: 2.5 mg per vial, 30 glass vials per carton
Lot Numbers:
1H005 (Exp Nov 30, 2023)
NDC:
65174-270-30

Rx Only

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 90455
Status: Resolved
Manufacturer: Jubilant Draximage Inc
Sold By: retailers nationwide
Manufactured In: Canada
Units Affected: 519 cartons/30 vials each
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.