Exact FDA event identifier

Event 94653

1 recalled-product record grouped only because every row carries this exact official event ID.

Event summary

Timeline bucket: May 20, 2024
Product types: Drug
Classifications: Class II
Statuses: Terminated
Recalling firm wording: Genentech, Inc.

Dossier provenance

Source snapshots represented here

openFDA Drug Enforcement Report-date coverage June 20, 2012–July 08, 2026 Known gap: openFDA describes 2004-present coverage, but the current export has no report-date records in this interval.

Enforcement coverage uses report dates; product initiation dates can precede those bounds. Device-enrichment coverage uses FDA event_date_initiated.

How coverage and grouping work

Device root-cause evidence is not applicable to this event. No grouped product has the official product type device; this is not an unavailable-enrichment finding.

Complete imported group

Every recalled product in this event

1 official enforcement rows

Product dates, classifications, firms, and source wording remain attached to their individual rows. Opening this dossier never hides products that did not match a prior timeline filter.

drug · product 1 of 1

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

D-0509-2024

Recall number: D-0509-2024
Initiated: May 20, 2024
Classification: Class II
Status: Terminated
Recalling firm: Genentech, Inc.
Quantity: Lot:3618858 = 105,759; Lot:3618873 =90,359

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0

Lack of Assurance of Sterility

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

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

Code information

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

Distribution pattern

Nationwide within the United States