D-135-2013 Class I Terminated
FDA drug recall D-135-2013 was initiated by Genentech Inc on Jul 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… The recall status is terminated (terminated Mar 25, 2013). Affected quantity: 2,140 kits.
Recall Details
- Product Type
- Drugs
- Report Date
- Jan 30, 2013
- Initiation Date
- Jul 30, 2012
- Termination Date
- Mar 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)
Source
- Dataset
- openFDA drug recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for D-135-2013
- openFDA file date
- Nov 3, 2026
- Loaded by RegDataLab
- Nov 4, 2026