Class I
Terminated
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.
- Company
- Genentech, Inc.
- Recall Initiated
- July 30, 2012
- Posted
- January 30, 2013
- Recall Number
- D-135-2013
- Voluntary / Mandated
- Voluntary: Firm initiated
- Quantity
- 2,140 kits
- Firm Location
- South San Francisco, CA, United States
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.
Distribution
Nationwide
Lot / Code Info
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)
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