Why it was recalled
Presence of Particulate Matter: One lot of Bacteriostatic Water for Injection, USP diluent vials that were packed with Trastuzumab Kits for investigational use has the potential to contain glass particulates.
Product description
Trastuzumab Kit containing 1 vial Trastuzumab (nominal content: 440 mg); 1 20 mL multiple dose vial Bacteriostatic Water for Injection, USP (1.1% benzyl alcohol), Manufactured by Hospira, Inc., for Genentech, Inc., South San Francisco, CA 94080-4990, NDC 50242-903-69; and 1 Reconstitution Instructions per kit; Investigation Use only, Genentech, Inc., 1 DNA Way, South San Francisco, CA 94080-4990.
Lot numbers, UPCs & expiration codes
Lot #: 454138, Exp 07/14 (containing Trastuzumab Lot #: 886618, Exp 12/14; and Bacteriostatic Water for Injection, USP Lot #: 08-368-DK-01, Exp 07/14)
Where it was sold
Nationwide
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-135-2013
- Classification
- Class I
- Status
- Terminated
- Recall initiated
- Jul 30, 2012
- FDA report date
- Jan 30, 2013
- Quantity
- 2,140 kits
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Genentech Inc
Original FDA data
Every field from FDA enforcement report D-135-2013, exactly as published.
Show all FDA fields
- City
- South San Francisco
- State
- CA
- Status
- Terminated
- Country
- United States
- Event ID
- 63258
- Address
- 1 DNA Way
- Code information
- Lot #: 454138, Exp 07/14 (containing Trastuzumab Lot #: 886618, Exp 12/14; and Bacteriostatic Water for Injection, USP Lot #: 08-368-DK-01, Exp 07/14)
- Postal code
- 94080-4990
- Report date
- Jan 30, 2013
- Product type
- Drugs
- Recall number
- D-135-2013
- Classification
- Class I
- Recalling firm
- Genentech Inc
- Product quantity
- 2,140 kits
- Termination date
- Mar 25, 2013
- Reason for recall
- Presence of Particulate Matter: One lot of Bacteriostatic Water for Injection, USP diluent vials that were packed with Trastuzumab Kits for investigational use has the potential to contain glass particulates.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Trastuzumab Kit containing 1 vial Trastuzumab (nominal content: 440 mg); 1 20 mL multiple dose vial Bacteriostatic Water for Injection, USP (1.1% benzyl alcohol), Manufactured by Hospira, Inc., for Genentech, Inc., South San Francisco, CA 94080-4990, NDC 50242-903-69; and 1 Reconstitution Instructions per kit; Investigation Use only, Genentech, Inc., 1 DNA Way, South San Francisco, CA 94080-4990.
- Distribution pattern
- Nationwide
- Recall initiation date
- Jul 30, 2012
- Initial firm notification
- Center classification date
- Jan 22, 2013