FDA recall D-0425-2018

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

Reason for recall

Defective Container: Confirmed reports of loose vial crimps.

Distribution

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

Key facts

Status

Terminated

Initiation date

2018-01-30

Report date

2018-02-14

Termination date

2018-12-12

Voluntary/Mandated

Voluntary: Firm initiated

Location

Cambridge, MA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0425-2018