Class II · Moderate risk
Bortezomib for Injection 3.5mg/Vial
Lack of Sterility Assurance
VELCADE (bortezomib)
Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.
Why it was recalled
Defective Container: Confirmed reports of loose vial crimps.
Cause type: Packaging defect
Failed child-resistant closures, leaks, cracked containers, or a defective delivery device. Packaging failures risk accidental exposure (especially to children) or product contamination. All packaging defect recalls.
What was recalled
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
Affected NDC
63020-0049-01
Compare with the code on your package — it is the most precise check available.
Drug: Bortezomib
Product details
From the FDA NDC directory, for the product code this recall names. Compare with the label on your package.
| Product | Strength | Form & route | Labeler | Type |
|---|---|---|---|---|
| Velcade bortezomib NDC 63020-0049 |
3.5 mg/1 | Injection, Powder, Lyophilized, for Solution Intravenous|subcutaneous |
Takeda Pharmaceuticals America, Inc. | Rx |
- Recalling firm
- Millennium Pharmaceuticals Inc.
- NDC code
- 63020-0049-01
- Origin
- MA, United States
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-0425-2018 · FDA notice
Check, then ask. Class II means harm is possible but usually temporary or reversible. Find the lot number on your package; if it matches, ask your pharmacist about a replacement. Do not simply stop a prescribed medication on your own - the gap can be riskier than the recall. This recall is now terminated, which means the firm has finished removing the affected product; anything on pharmacy shelves today should be unaffected.
Other Bortezomib recalls
See all
Class III · Low risk
Bortezomib
Failed stability specifications
Class II · Moderate risk
BORTEZOMIB 2.5 mg / 1 ML SQ SYRINGE
Lack of Assurance of Sterility
Other packaging defect recalls from 2018
All packaging defect recalls
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Class II · Moderate risk
Omnipaque (iohexol)
Defective Container: vial defect was identified that could potentially impact the container closure and result in a lack of sterility assurance and/or the potential for glass particles.
Class III · Low risk
Testosterone Topical Solution
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Class III · Low risk
Contrave (naltrexone HCl and bupropion HCl)
Container packaging defect.
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