FDAFDA · Food and drugs·Recall number D-0425-2018
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
Published February 14, 2018 · Recall initiated: January 30, 2018
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Defective Container: Confirmed reports of loose vial crimps.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Millennium Pharmaceuticals Inc.
- Distributor
- Distributed nationwide. They estimate 4% of the product may be recovered.
- Lot
- Lot Numbers # 224161, 224546 and 224547; Exp. 12/19
- Risk classification
- Class II
- Area (FDA)
- drug
- Country
- United States
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