Class II
Drug Recall: Cathflo activase (ALTEPLASE), 2mg vials, Rx only, Genentech Inc., South San Francisco, CA 94080, NDC 50242-041-64
Genentech, Inc. · May 20, 2024
Reason for Recall
Lack of Assurance of Sterility: Deformed stoppers observed during filling operations for Cathflo Activase.
Distribution
Nationwide within the United States
States Affected
NATIONWIDE
Quantity Affected
Lot:3618858 = 105,759; Lot:3618873 =90,359
Source: FDA (openFDA Drug Enforcement)
Recall number: D-0509-2024
Status: terminated
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