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 MonitoringReason 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 openFDA enforcement API. 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.