Drug recall D-0509-2024

Class II Terminated reported Jun 5, 2024

Product

Cathflo activase (ALTEPLASE), 2mg vials, Rx only, Genentech Inc., South San Francisco, CA 94080, NDC 50242-041-64

Reason for recall

Lack of Assurance of Sterility: Deformed stoppers observed during filling operations for Cathflo Activase.

Lots and codes

Lot #: 3618858, 3618873, Exp. Date 01/31/2026

Recall details

Recalling firm
Genentech, Inc., South San Francisco, CA
Quantity
Lot:3618858 = 105,759; Lot:3618873 =90,359
Distribution
Nationwide within the United States
Type
Voluntary: Firm initiated
Recall initiated
May 20, 2024
Terminated
August 11, 2025

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