July 2012 FDA Recall Drug by Genentech Inc
D-135-2013 - Presence of Particulate Matter

This Class I drug recall was voluntarily initiated by Genentech Inc on July 30, 2012 for the product Drug. The FDA reported the reason for recall as presence of particulate matter. The product was distributed Nationwide and the recall is currently terminated.

Recall Number: D-135-2013

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.
Initiated
07-30-2012
Reported
01-30-2013
Quantity
2,140 kits

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
63258
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class I - is a situation in which there is a reasonable probability that the use of, or exposure to, a violative product will cause serious adverse health consequences or death.
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Genentech Inc
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
E-Mail
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide
Termination Date About Termination Date
Date that FDA officially terminated the recall.
03-25-2013
Product Description About Product Description
Full technical description of the product.
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.

Batch or Lot Expiration 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)