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 concent

FDA recall notice · announced February 14, 2018 · Millennium Pharmaceuticals

Class II FDA/FSIS Class II: use may cause temporary or medically reversible adverse health consequences.

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

Reason for recall

Defective Container: Confirmed reports of loose vial crimps.

Notes

Distribution: Distributed nationwide. They estimate 4% of the product may be recovered.
Lot/code information: Lot Numbers # 224161, 224546 and 224547; Exp. 12/19
Quantity: 154,372 vials
Status: Terminated
Products in this recall event:
- 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 O (D-0425-2018)

Source: U.S. Food and Drug Administration public recall data. This page reports official records and is not legal, medical, or repair advice.