Medications & Supplements/Prescription Drugs

Pharmalucence, Inc.: Technetium Tc99m Medronate Kit Recalled for Potential Sterility Breach

Agency Publication Date: August 3, 2018

Summary

Pharmalucence, Inc. has recalled 95 kits of Technetium Tc99m Medronate, a diagnostic drug used for bone imaging, because of a reported breach of sterility. The recall affects both 5-count boxes (NDC 45567-0040-1) and 30-count boxes (NDC 45567-0040-2) from lot 4223. A lack of sterility in an injectable medication can lead to serious, life-threatening infections if the product is contaminated. This product was distributed nationwide to healthcare facilities. Patients who may have received this medication should contact their healthcare provider or pharmacist, as the sterility of the product cannot be guaranteed.

Risk

A breach of sterility means the drug may be contaminated with microorganisms like bacteria or fungi. Because this medication is injected directly into the body, any contamination poses a significant risk of causing serious infections or sepsis.

What You Should Do

Check your medical inventory or patient records for Technetium Tc99m Medronate Kit (20mg in 10 mL vial) with Lot Number 4223.
Verify the NDC numbers on the packaging: 45567-0040-1 for the 5-count box or 45567-0040-2 for the 30-count box.
Immediately stop using any vials from the affected lot and quarantine the remaining stock to prevent further use.
Contact your healthcare provider or pharmacist if you have recently undergone a procedure using this specific lot of Technetium Tc99m Medronate.
Return any unused product from Lot 4223 to the place of purchase for a refund and contact Pharmalucence, Inc. for further return and disposal instructions.
For additional information or to report adverse events, 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

Healthcare provider guidance and product refund

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

Affected Products

Product: Technetium Tc99m Medronate Kit, 20mg in 10 mL vial (5-count box)

Model:

NDC 45567-0040-1

Lot Numbers:

4223

Product: Technetium Tc99m Medronate Kit, 20mg in 10 mL vial (30-count box)

Model:

NDC 45567-0040-2

Lot Numbers:

4223

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 80428

Status: Resolved

Manufacturer: Pharmalucence, Inc.

Sold By: Hospitals; Medical clinics; Diagnostic imaging centers

Manufactured In: United States

Units Affected: 95 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 · 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 or patient records for Technetium Tc99m Medronate Kit (20mg in 10 mL vial) with Lot Number 4223.

Verify the NDC numbers on the packaging: 45567-0040-1 for the 5-count box or 45567-0040-2 for the 30-count box.

Immediately stop using any vials from the affected lot and quarantine the remaining stock to prevent further use.

Contact your healthcare provider or pharmacist if you have recently undergone a procedure using this specific lot of Technetium Tc99m Medronate.

Return any unused product from Lot 4223 to the place of purchase for a refund and contact Pharmalucence, Inc. for further return and disposal instructions.

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