Why it was recalled
Defective Container: Confirmed reports of loose vial crimps.
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
Lot numbers, UPCs & expiration codes
Lot Numbers # 224161, 224546 and 224547; Exp. 12/19
Where it was sold
Distributed nationwide. They estimate 4% of the product may be recovered.
What to do if you have this product
- Compare the lot number and expiration date on your package with the codes above.
- Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
- If you have symptoms you think are related, contact your doctor. In an emergency call 911.
- Report side effects to FDA MedWatch at 1-800-FDA-1088.
Recall details
- Recall number
- D-0425-2018
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Jan 30, 2018
- FDA report date
- Feb 14, 2018
- Quantity
- 154,372 vials
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Millennium Pharmaceuticals Inc.
Original FDA data
Every field from FDA enforcement report D-0425-2018, exactly as published.
Show all FDA fields
- City
- Cambridge
- State
- MA
- Status
- Terminated
- Country
- United States
- Event ID
- 79083
- Address
- 40 Landsdowne St
- Code information
- Lot Numbers # 224161, 224546 and 224547; Exp. 12/19
- Postal code
- 02139-4234
- Report date
- Feb 14, 2018
- Product type
- Drugs
- Recall number
- D-0425-2018
- Classification
- Class II
- Recalling firm
- Millennium Pharmaceuticals Inc.
- Product quantity
- 154,372 vials
- Termination date
- Dec 12, 2018
- Reason for recall
- Defective Container: Confirmed reports of loose vial crimps.
- Voluntary / mandated
- Voluntary: Firm initiated
- 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
- Distribution pattern
- Distributed nationwide. They estimate 4% of the product may be recovered.
- Recall initiation date
- Jan 30, 2018
- Initial firm notification
- Letter
- Center classification date
- Feb 14, 2018