September 2017 FDA Recall Drug by Genentech, Inc.
D-1175-2017 - Non-Sterility

This Class I drug recall was voluntarily initiated by Genentech, Inc. on September 5, 2017 for the product Drug. The FDA reported the reason for recall as non-sterility. The product was distributed Nationwide and the recall is currently terminated.

Recall Number: D-1175-2017

Reason for Recall
Non-Sterility:presence of cracked or chipped glass at the neck of Sterile Water for Injection vials.
Initiated
09-05-2017
Reported
09-27-2017
Quantity
16,882

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
78088
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.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide in the USA
Termination Date About Termination Date
Date that FDA officially terminated the recall.
01-11-2019
Product Description About Product Description
Full technical description of the product.
Activase (alteplase), 100 mg (58 million IU), Lyophilized vial, packaged with 1 single-dose 100ml vial of sterile water for Injection USP and one transfer device. Manufactured by: Genentech, Inc. 1 DNA Way, South San Francisco, CA 84080-4990. NDC: 50242-0085-27

Batch or Lot Expiration Information

Lot# 3128243, 3141239, EXP. 9/30/2018; 3166728, EXP. 2/28/2019.