Reported Jun 5, 2024 · Terminated
Cathflo activase (ALTEPLASE), 2mg vials, Rx only, Genentech Inc., South San Francisco, CA 94080, NDC 50242-041-64
Genentech, Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.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 Bldg 5 · South San Francisco, CA · 94080-4918
Is this the product you have?
- Cathflo activase (ALTEPLASE), 2mg vials, Rx only, Genentech Inc., South San Francisco, CA 94080, NDC 50242-041-64
- Lot codes and dates
Lot #: 36188583618873Exp. Date 01/31/2026
- Amount recalled
- Lot:3618858 = 105,759; Lot:3618873 =90,359
Where it was sold
- Nationwide
Why it was recalled
Lack of Assurance of Sterility: Deformed stoppers observed during filling operations for Cathflo Activase.
This product could cause temporary or reversible health problems — stop using it.
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