VELCADE — Class II drug recall D-0425-2018
Terminated recall by Millennium Pharmaceuticals Inc., reported 2018-02-14, distributed nationwide. Defective Container: Confirmed reports of loose vial crimps.
| Recall number | D-0425-2018 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Millennium Pharmaceuticals Inc., Cambridge, MA, United States |
| Recall initiated | 2018-01-30 |
| Classified | 2018-02-14 |
| Reported by FDA | 2018-02-14 |
| Terminated | 2018-12-12 |
| Distributed | Nationwide (US) |
| Quantity | 154,372 vials |
| Reason classes | packaging |
| NDC | 63020-0049-01 |
| Lot numbers | 12/19, 224161, 224546, 224547 |
Product
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
Reason for recall
Defective Container: Confirmed reports of loose vial crimps.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/D-0425-2018. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.