Enforcement Report - Week of January 30, 2013
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Product Detail
| 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. |
|---|---|
| Recall Number | D-135-2013 |
| Classification | Class I |
| 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) |
| Product Distributed Qty | 2,140 kits |
| 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. |
Event Detail
| Event Id | 63258 |
|---|---|
| Product Type | Drugs |
| Status | Completed |
| Recalling Firm | Genentech Inc |
| City | South San Francisco |
| State | CA | Country | US |
| Voluntary / Mandated | Voluntary: Firm Initiated |
| Recall Initiation Date | 2012-07-30 |
| Initial Firm Notification of Consignee or Public | |
| Distribution Pattern | Nationwide |
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