← FDA ENFORCEMENT
D-0509-2024Class II

Genentech, Inc.

What this record is not

A recall record is reproduced as FDA published it, and the classification is FDA’s. SPEQ adds no interpretation, and a recall concerns the products and dates in the record — it is not a statement about a company’s other products or its current status.

Recalling firm
Genentech, Inc.
Product type
Drug
Status
Terminated
Report date
2024-06-05
Distribution
Nationwide within the United States
Firm state
CA
Product quantity
Lot:3618858 = 105,759; Lot:3618873 =90,359
Initiated by
Voluntary: Firm initiated
SPEQ quality domain
Environmental Monitoring
Reason for recall

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

Product description

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

Code / lot info

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

Other recalls SPEQ maps to Environmental Monitoring
See all Environmental Monitoring recalls →

Data: U.S. FDA. Recall details are as reported by the FDA. The quality-domain mapping and severity are a SPEQ editorial interpretation of the recall reason, not an official FDA classification. Open the enforcement explorer →