Class II
Terminated
Cathflo activase (ALTEPLASE), 2mg vials, Rx only, Genentech Inc., South San Francisco, CA 94080, NDC 50242-041-64
- Company
- Genentech, Inc.
- Recall Initiated
- May 20, 2024
- Posted
- June 5, 2024
- Recall Number
- D-0509-2024
- Voluntary / Mandated
- Voluntary: Firm initiated
- Quantity
- Lot:3618858 = 105,759; Lot:3618873 =90,359
- Firm Location
- South San Francisco, CA, United States
Reason for Recall
Lack of Assurance of Sterility: Deformed stoppers observed during filling operations for Cathflo Activase.
Distribution
Nationwide within the United States
Lot / Code Info
Lot #: 3618858, 3618873, Exp. Date 01/31/2026
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