Drug Enforcement D-0509-2024

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

Status

Terminated

Classification

Class II

Report Date

June 5, 2024

Termination Date

August 11, 2025

Product Information

Product description
Cathflo activase (ALTEPLASE), 2mg vials, Rx only, Genentech Inc., South San Francisco, CA 94080, NDC 50242-041-64
Product quantity
Lot:3618858 = 105,759; Lot:3618873 =90,359
Reason for recall
Lack of Assurance of Sterility: Deformed stoppers observed during filling operations for Cathflo Activase.
Recall initiation reason
—
Initial firm notification
Letter
Distribution pattern
Nationwide within the United States

Location & Firm

Recalling firm
Genentech, Inc.
Address
1 Dna Way Bldg 5

United States
Voluntary / Mandated
Voluntary: Firm initiated
Status date
—

Codes & Dates

Recall number
D-0509-2024
Event ID
94653
Recall initiation date
May 20, 2024
Center classification date
May 24, 2024
Code info
Lot #: 3618858, 3618873, Exp. Date 01/31/2026
More code info
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