January 2018 FDA Recall Drug by Millennium Pharmaceuticals Inc.
D-0425-2018 - Defective Container

This Class II drug recall was voluntarily initiated by Millennium Pharmaceuticals Inc. on January 30, 2018 for the product Drug. The FDA reported the reason for recall as defective container. The product was distributed Nationwide and the recall is currently terminated.

Recall Number: D-0425-2018

Reason for Recall
Defective Container: Confirmed reports of loose vial crimps.
Initiated
01-30-2018
Reported
02-14-2018
Quantity
154,372 vials

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
79083
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Millennium Pharmaceuticals Inc.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Distributed nationwide. They estimate 4% of the product may be recovered.
Termination Date About Termination Date
Date that FDA officially terminated the recall.
12-12-2018
Product Description About Product Description
Full technical description of the 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

Batch or Lot Expiration Information

Lot# Lot Numbers # 224161, 224546 and 224547; Exp. 12/19