Reported Sep 27, 2017 · Terminated

Activase (alteplase), 100 mg (58 million IU), Lyophilized vial, packaged with 1 single-dose 100ml vial of sterile water…

Genentech, Inc.

High riskUsing this product could cause serious injury, illness or death — stop using it now.

What you should do

Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.

Firm contact: Genentech, Inc. · 1 Dna Way · South San Francisco, CA · 94080-4990

Is this the product you have?

  • 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 byGenentech, Inc. 1 DNA Way, South San Francisco, CA 84080-4990
  • NDC50242-0085-27
Lot codes and dates
    • Lot# 3128243
    • 3141239
    • EXP. 9/30/2018
    • 3166728
    • EXP. 2/28/2019
Amount recalled
16,882

Where it was sold

  • Nationwide

Why it was recalled

Stop using this product now

Non-Sterility:presence of cracked or chipped glass at the neck of Sterile Water for Injection vials.

Using this product could cause serious injury, illness or death — stop using it now.

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Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA drug enforcement) notice

Notice updated Jan 11, 2019 · Data as of Sep 19, 6:23 PM UTC

RecallNow is not a government agency. Every fact on this page is published by the FDA, USDA or CPSC and links back to their notice.