Medications & Supplements/Prescription Drugs

Millennium Pharmaceuticals Inc.: Velcade (bortezomib) for Injection Recalled for Defective Vial Seals

Agency Publication Date: February 8, 2018

Summary

Millennium Pharmaceuticals Inc. is recalling 154,372 vials of Velcade (bortezomib) for injection, a prescription medication used to treat certain types of cancer. The recall was initiated because of confirmed reports that the metal crimps securing the vial containers are loose, which can compromise the sterile seal of the drug. These affected vials were distributed nationwide across the United States.

Risk

A loose vial crimp can lead to a loss of container integrity, potentially allowing contaminants to enter the vial and compromise the sterility of the medication. Injecting a non-sterile drug product into a patient can cause serious, life-threatening infections or other severe health complications.

What You Should Do

Check your medication to see if it is VELCADE (bortezomib) for injection, 3.5 mg/vial, with NDC 63020-0049-01.
Verify the lot numbers and expiration date on the vial packaging. Affected lot numbers are 224161, 224546, and 224547, all with an expiration date of 12/19.
If you have any vials from the affected lots, do not use them. Contact your healthcare provider or pharmacist immediately for guidance on obtaining a safe replacement.
Return any unused vials from these specific lots to your pharmacy for a refund and further instructions.
Healthcare professionals and patients should report any adverse events or quality problems to the FDA's MedWatch Safety Information and Adverse Event Reporting Program.
For more information or additional questions, contact the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA).

Your Remedy Options

Full Refund

Healthcare provider consultation and pharmacy return

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

Affected Products

Product: VELCADE (bortezomib) for injection (3.5 mg/vial)

Model:

NDC 63020-0049-01

Lot Numbers:

224161 (Exp. 12/19)

224546 (Exp. 12/19)

224547 (Exp. 12/19)

Date Ranges: Exp. 12/19

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 79083

Status: Resolved

Manufacturer: Millennium Pharmaceuticals Inc.

Sold By: pharmacies; hospitals; healthcare providers

Manufactured In: United States

Units Affected: 154,372 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 medication to see if it is VELCADE (bortezomib) for injection, 3.5 mg/vial, with NDC 63020-0049-01.

Verify the lot numbers and expiration date on the vial packaging. Affected lot numbers are 224161, 224546, and 224547, all with an expiration date of 12/19.

If you have any vials from the affected lots, do not use them. Contact your healthcare provider or pharmacist immediately for guidance on obtaining a safe replacement.

Return any unused vials from these specific lots to your pharmacy for a refund and further instructions.

Healthcare professionals and patients should report any adverse events or quality problems to the FDA's MedWatch Safety Information and Adverse Event Reporting Program.

For more information or additional questions, contact the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA).