Genentech recalls 2mg Cathflo Activase vials with deformed stoppers that may cause contamination. Affected lots expire 01/31/2026. Stop using immediately to avoid infection risks.
Lack of Assurance of Sterility: Deformed stoppers observed during filling operations for Cathflo Activase.
Genentech is recalling 2mg Cathflo Activase vials that have deformed stoppers during manufacturing. This could lead to contamination if the vial is used, posing a risk of infection. Affected vials have specific lot numbers and expire by January 31, 2026.
Deformed stoppers during filling operations can allow contaminants to enter the vial. This creates a risk of infection when the medication is administered to patients. The hazard is serious because the vial is used for critical medical treatment.
Prescription users of Cathflo Activase 2mg vials with lot numbers 3618858 or 3618873. Patients using these vials for clotting treatment are at risk of infection if the vial is used.
Check for vials labeled 'Cathflo Activase (ALTEPLASE), 2mg' with lot numbers 3618858 or 3618873. These vials expire by January 31, 2026, and were manufactured by Genentech in South San Francisco.
Discard any vials with lot numbers 3618858 or 3618873 to prevent potential contamination.
Deformed stoppers observed during filling operations that could allow contaminants to enter the vial.
Lot numbers 3618858 and 3618873.
The affected vials expire on January 31, 2026.
We’ve drafted a message you can send Genentech to request your refund or repair — edit it as you like.
Subject: Recall D-0509-2024 — Genentech Genentech Hello, I own a Genentech that is covered by recall D-0509-2024 from Genentech. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
