Exact FDA event identifier

Event 78088

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

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Event summary

Timeline bucket: September 05, 2017
Product types: Drug
Classifications: Class I
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

Activase (alteplase), 100 mg (58 million IU), Lyophilized vial, packaged with 1 single-dose 100ml vial of sterile water for Injection USP and one transfer device. Manufactured by: Genentech, Inc. 1 DNA Way, South San Francisco, CA 84080-4990. NDC: 50242-0085-27

D-1175-2017

Recall number: D-1175-2017
Initiated: September 05, 2017
Classification: Class I
Status: Terminated
Recalling firm: Genentech, Inc.
Quantity: 16,882

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0

Non-Sterility:presence of cracked or chipped glass at the neck of Sterile Water for Injection vials.

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Non-Sterility:presence of cracked or chipped glass at the neck of Sterile Water for Injection vials.

Code information

Lot# 3128243, 3141239, EXP. 9/30/2018; 3166728, EXP. 2/28/2019.

Distribution pattern

Nationwide in the USA