Drug FDA Class II Terminated Contamination / non-sterility
Cathflo activase (ALTEPLASE), 2mg vials, Rx only, Genentech Inc., South San Francisco, CA 94080, NDC 50242-041-64
Genentech, Inc. Published Jun 5, 2024
Risk level
Class IIMay cause a temporary or reversible health problem; slight chance of serious harm.
Severity score 55/100
What should you do?
- Check whether you have this product, using the lot codes, UPCs, and dates listed below.
- Do not eat, serve, or sell the affected product.
- Return it to the place of purchase for a refund, or throw it away in a sealed bag so people and animals can’t get to it.
- Contact Genentech, Inc. or your place of purchase with questions, and see the source record below for full details.
Reason for recall
Lack of Assurance of Sterility: Deformed stoppers observed during filling operations for Cathflo Activase.
Hazards
Lack of Sterility Assurance from Deformed Stoppers · primary
Affected products (1)
Cathflo activase (ALTEPLASE), 2mg vials, Rx only, Genentech Inc., South San Francisco, CA 94080, NDC 50242-041-64
CATHFLO ACTIVASE · Lot:3618858 = 105,759; Lot:3618873 =90,359
NDC: 50242-041, 50242-041-64, 50242-041-10
Code info: Lot #: 3618858, 3618873, Exp. Date 01/31/2026
Affected areas
Nationwide
Timeline
- InitiatedMay 20, 2024
- PublishedJun 5, 2024
- TerminatedAug 11, 2025
- Recall number
- D-0509-2024
- Agency
- U.S. Food and Drug Administration
- Country
- US
FDA records come from the openFDA drug enforcement-report dataset — the agency's full weekly enforcement list. Most entries are not issued as consumer press releases, so they won't appear on fda.gov/recalls or in a web search. The source record link above resolves this exact recall by its number.