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
Reported: February 14, 2018 Initiated: January 30, 2018 #D-0425-2018
Product Description
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.
Details
- Recalling Firm
- Millennium Pharmaceuticals Inc.
- Units Affected
- 154,372 vials
- Distribution
- Distributed nationwide. They estimate 4% of the product may be recovered.
- Location
- Cambridge, MA
Frequently Asked Questions
What product 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. Recalled by Millennium Pharmaceuticals Inc.. Units affected: 154,372 vials.
Why was this product recalled? ▼
Defective Container: Confirmed reports of loose vial crimps.
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on February 14, 2018. Severity: Moderate. Recall number: D-0425-2018.
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