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

FDA recall notice · announced June 5, 2024 · Genentech

Class II FDA/FSIS Class II: use may cause temporary or medically reversible adverse health consequences.

The 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.

Notes

Distribution: Nationwide within the United States
Lot/code information: Lot #: 3618858, 3618873, Exp. Date 01/31/2026
Quantity: Lot:3618858 = 105,759; Lot:3618873 =90,359
Status: Terminated
Products in this recall event:
- Cathflo activase (ALTEPLASE), 2mg vials, Rx only, Genentech Inc., South San Francisco, CA 94080, NDC 50242-041-64 (D-0509-2024)

Source: U.S. Food and Drug Administration public recall data. This page reports official records and is not legal, medical, or repair advice.