Millennium Pharmaceuticals Inc. recalls VELCADE (bortezomib) for injection, 3.5 mg/vial, Reconstitution Information, SUBCUTANEOUS INJECTION ONLY add 1.4 mL 0.9%
Recalled February 14, 2018 · FDA recall D-0425-2018 · Millennium Pharmaceuticals
Hazard
Defective Container: Confirmed reports of loose vial crimps. · FDA Class II
Units
154,372 vials
Sold at
Distributed nationwide. They estimate 4% of the product may be recovered.
Description
Defective Container: Confirmed reports of loose vial crimps.
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
Manufacturer(s)
Millennium Pharmaceuticals Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →