FDA Drug recall 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…
- FDA Drug
- Class II
- terminated
- Published 2018-02-14
On 2018-02-14 the FDA classified a Class II recall of VELCADE (bortezomib) for injection, 3.5 mg/vial, Reconstitution Information, SUBCUTANEOUS INJECTION ONLY add 1.4 mL 0.9% Sodium Chloride to… by Millennium Pharmaceuticals, citing defective Container: Confirmed reports of loose vial crimps.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-0425-2018 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2018-01-30 |
| Published | 2018-02-14 |
| Last updated | 2026-09-13 11:52 UTC |
| Company | Millennium Pharmaceuticals |
| Distribution | US |
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
Defective Container: Confirmed reports of loose vial crimps.
Identifiers
| code_info | Lot Numbers # 224161, 224546 and 224547; Exp. 12/19 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:52 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0425-2018%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.