Medications & Supplements/Prescription Drugs

Jubilant Draximage Inc: DRAXIMAGE DTPA Kits Recalled for Failed Stability Specifications

Agency Publication Date: March 25, 2020

Summary

Approximately 473 kits (each containing 30 vials) of DRAXIMAGE DTPA (technetium Tc 99m pentetate injection) 20 mg are being recalled because the medication failed to meet stability specifications. This prescription kit is used by medical professionals to prepare diagnostic injections, and failing stability tests means the product may not remain effective or safe through its intended shelf life. The recall affects product distributed throughout the United States, and consumers or healthcare providers should contact their pharmacist or the manufacturer for guidance.

Risk

When a drug fails stability specifications, it may lose potency or undergo chemical changes before its expiration date. This can lead to inaccurate diagnostic imaging results or potential adverse reactions during medical procedures.

What You Should Do

Check your medical inventory for DRAXIMAGE DTPA (technetium Tc 99m pentetate injection) 20 mg kits with NDC numbers 65174-288-05 or 67175-288-30.
Identify if your kit belongs to Lot # 8K143 with an expiration date of 10/31/2020.
If you have the affected lot, stop using it immediately and secure the product to ensure it is not administered to patients.
Contact your healthcare provider or pharmacist for guidance if you are a patient who has recently undergone a procedure using this kit.
Return any unused product from the affected lot to the pharmacy or place of purchase for a refund and contact Jubilant Draximage Inc. for specific return instructions.
For additional questions or to report a concern, contact the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA) or visit www.fda.gov/safety/recalls.

Your Remedy Options

Full Refund

Return for refund and pharmacy guidance.

How to: Contact your healthcare provider or pharmacist for guidance. Return any unused product to the pharmacy for a refund and contact the manufacturer for further instructions.

Affected Products

Product: DRAXIMAGE DTPA (KIT FOR THE PREPARATION OF TECHNETIUM TC 99M PENTETATE INJECTION), 20 mg vial

Model:

NDC 65174-288-05

67175-288-30

Recall #: D-1062-2020

Lot Numbers:

8K143 (Exp 10/31/2020)

Date Ranges: Expiration date 10/31/2020

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 85226

Status: Resolved

Manufacturer: Jubilant Draximage Inc

Sold By: Hospitals; Diagnostic Imaging Centers; Pharmacies

Manufactured In: Canada

Units Affected: 473 kits of 30 vials

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 · 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.

Summary

What You Should Do

Check your medical inventory for DRAXIMAGE DTPA (technetium Tc 99m pentetate injection) 20 mg kits with NDC numbers 65174-288-05 or 67175-288-30.

Identify if your kit belongs to Lot # 8K143 with an expiration date of 10/31/2020.

If you have the affected lot, stop using it immediately and secure the product to ensure it is not administered to patients.

Contact your healthcare provider or pharmacist for guidance if you are a patient who has recently undergone a procedure using this kit.

Return any unused product from the affected lot to the pharmacy or place of purchase for a refund and contact Jubilant Draximage Inc. for specific return instructions.

For additional questions or to report a concern, contact the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA) or visit www.fda.gov/safety/recalls.