D-0425-2018 Class II Terminated
Recall Details
- Product Type
- Drugs
- Report Date
- February 14, 2018
- Initiation Date
- January 30, 2018
- Termination Date
- December 12, 2018
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 154,372 vials
Product Description
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.
Distribution Pattern
Distributed nationwide. They estimate 4% of the product may be recovered.
Code Information
Lot Numbers # 224161, 224546 and 224547; Exp. 12/19