Reported Feb 14, 2018 · Terminated

VELCADE (bortezomib) for injection, 3.5 mg/vial, Reconstitution Information, SUBCUTANEOUS INJECTION ONLY add 1.4 mL…

Millennium Pharmaceuticals Inc.

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

What you should do

Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.

Firm contact: Millennium Pharmaceuticals Inc. · 40 Landsdowne St · Cambridge, MA · 02139-4234

Is this the product you have?

  • VELCADE (bortezomib) for injection, 3.5 mg/vial, Reconstitution Information, SUBCUTANEOUS INJECTION ONLY add 1.4 mL 0.9% Sodium Chloride to make 2.5 mg/ mL final concentration, INTRAVENOUS INJECTION ONLY add 3.5 mL Sodium Chloride to 1 mg/mL final concentration, Rx Only, Distributed by MILLENNIUM Pharmaceuticals, Inc., Cambridge, MA 02139-4234, NDC 63020-0049-01
Lot codes and dates
    • Lot Numbers # 224161
    • 224546 and 224547
    • Exp. 12/19
Amount recalled
154,372 vials

Where it was sold

  • Nationwide

Why it was recalled

Defective Container: Confirmed reports of loose vial crimps.

This product could cause temporary or reversible health problems — stop using it.

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Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA drug enforcement) notice

Notice updated Dec 12, 2018 · Data as of Sep 19, 5:54 PM UTC

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