Millennium Pharmaceuticals Inc. recalls VELCADE (bortezomib) for injection, 3.5 mg/vial, Reconstitution Information, SUBCUTANEOUS INJECTION ONLY add 1.4 mL 0.9…

Recall date

January 30, 2018

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

D-0425-2018

FDA classification

Class II

Brand / firm

Millennium Pharmaceuticals Inc.

Sold / distributed

Distributed nationwide. They estimate 4% of the product may be recovered.

Why it was recalled

Defective Container: Confirmed reports of loose vial crimps.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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