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U.S. Department of Health and Human Services

Enforcement Report - Week of January 30, 2013

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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

Product Detail

Product Description Code Info Classification Reason for Recall Product Quantity Recall Number
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 #: 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) Class I 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. 2,140 kits D-135-2013