# FDA recall D-0425-2018

> **Millennium Pharmaceuticals Inc.** · Class II · drug recall initiated 2018-01-30.

## 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

- **Recall number:** D-0425-2018
- **Recalling firm:** Millennium Pharmaceuticals Inc.
- **Classification:** Class II
- **Product type:** drug
- **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

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

## Citation

> AI Analytics. FDA recall D-0425-2018. Retrieved 2026-06-24 from https://api.ai-analytics.org/recall/D-0425-2018. Source: US FDA. Licensed CC0.

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