FDA-Drug2018-02-14Class II
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
Millennium Pharmaceuticals Inc.
Hazard
Defective Container: Confirmed reports of loose vial crimps.
Sold states
Distributed nationwide. They estimate 4% of the product may be recovered.
Affected count
154,372 vials
Manufactured in
40 Landsdowne St, N/A, Cambridge, MA, United States
Products
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
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0425-2018Don't want to check this manually?
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