CLASS I Drug recall · Reported 27 Sep 2017 · FDA Enforcement Report
Activase (alteplase), 100 mg (58 million IU) recalled by Genentech
Genentech is recalling Activase (alteplase), 100 mg (58 million IU), Lyophilized vial, packaged with-dose vial, distributed nationwide in the US. The recall was initiated on 5 Sep 2017 and the FDA has classified it as Class I.
Check your package
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
Recall details
- Recall number
- D-1175-2017
- FDA event ID
- 78088
- Recalling firm
- Genentech, South San Francisco, CA
- Classification
- Class I
- Status
- Terminated
- Recall initiated
- 5 Sep 2017
- FDA classified
- 1 Dec 2017
- Reported
- 27 Sep 2017
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Foreign Material
- Drug class
- Injectable & IV Drugs
Timeline
| 5 Sep 2017 | Recall initiated by company | |
| 27 Sep 2017 | Published in enforcement report | +22 days |
| 1 Dec 2017 | Classified by FDA | +65 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Non-Sterility:presence of cracked or chipped glass at the neck of Sterile Water for Injection vials.
Foreign material recalls cover pieces of metal, plastic, glass, wood or other objects that got into the product during processing and could cause injury if eaten.
Product as listed by the FDA
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
Where it was distributed
Nationwide in the USA
Questions about this recall
Why was it recalled?
Non-Sterility:presence of cracked or chipped glass at the neck of Sterile Water for Injection vials.
Which lots are affected?
Lot# 3128243, 3141239, EXP. 9/30/2018; 3166728, EXP. 2/28/2019.
Where was it sold?
Nationwide in the USA
What should I do if I have it?
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
What does Class I mean?
Class I is the most serious FDA recall category: there is a reasonable probability that using the product will cause serious health consequences or death.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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|---|---|---|---|---|---|
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| Drug | CLASS III | Evrysdi (risdiplam) for oral solution, 60 mg recalled by Genentech | Genentech | Other | Nationwide |
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