Drug 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
D-0425-2018
Product summary
- Event
- Event 79083
- Status
- Terminated
- Classification
- Class II
- Quantity
- 154,372 vials
- Official record key
drug-enforcement:D-0425-2018
Official wording
Reason: Defective Container: Confirmed reports of loose vial crimps.
Code information: Lot Numbers # 224161, 224546 and 224547; Exp. 12/19
Distribution pattern: Distributed nationwide. They estimate 4% of the product may be recovered.
Derived failure modes
-
Unknown
Defective Container: Confirmed reports of loose vial crimps.