D-135-2013 Class I Terminated
FDA drug recall D-135-2013 was initiated by Genentech Inc on July 30, 2012 and is designated Class I. 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 parti… The recall status is terminated (terminated March 25, 2013). Affected quantity: 2,140 kits.
Recall Details
- Product Type
- Drugs
- Report Date
- January 30, 2013
- Initiation Date
- July 30, 2012
- Termination Date
- March 25, 2013
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 2,140 kits
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.
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 Pattern
Nationwide
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)