Cathflo activase (ALTEPLASE), 2mg vials, Rx only, Genentech Inc., South San Francisco, CA 94080, NDC 50242-041-64
Summary
The FDA issued a Class II for Cathflo activase (ALTEPLASE), 2mg vials, Rx only, Genentech Inc., South San Fran by Genentech, Inc.. Reason: Lack of Assurance of Sterility: Deformed stoppers observed during filling operations for Cathflo Activase..
Details
Source
Drug Recall
External ID
D-0509-2024
Action Date
2024-06-05
Status
Terminated
Category
drug
Product Description
Cathflo activase (ALTEPLASE), 2mg vials, Rx only, Genentech Inc., South San Francisco, CA 94080, NDC 50242-041-64
Lot/Code Info: Lot #: 3618858, 3618873, Exp. Date 01/31/2026
Quantity Affected: Lot:3618858 = 105,759; Lot:3618873 =90,359
Reason for Recall
Lack of Assurance of Sterility: Deformed stoppers observed during filling operations for Cathflo Activase.
Distribution
Nationwide within the United States
Type: Voluntary: Firm initiated
Recall Initiated: 2024-05-20
Company
South San Francisco, CA
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 115 drug recalls issued in the same week, part of 272 drug-related FDA actions this month.
Genentech, Inc. has 11 FDA actions in our database, including 3 recalls.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Genentech, Inc.) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Genentech, Inc. have FDA actions?
Genentech, Inc. has 11 FDA actions in our database, including 3 recalls and 0 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "D-0509-2024" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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