Exact FDA event identifier

Event 76542

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

Event summary

Timeline bucket: February 22, 2017
Product types: Drug
Classifications: Class II
Statuses: Terminated
Recalling firm wording: Endo Pharmaceuticals, 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

Edex (alprostadil for injection) 10mcg, packaged in a 2 pack carton, Rx only, Manufactured in Germany for: Actient Pharmaceuticals, LLC, Lake Forest, Illinois 60045; NDC 52244-010-02.

D-0512-2017

Recall number: D-0512-2017
Initiated: February 22, 2017
Classification: Class II
Status: Terminated
Recalling firm: Endo Pharmaceuticals, Inc.
Quantity: 5,086 cartridges

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: Defective container resulting in the lack of sterility assurance. ok thanks

Code information

Lot #: 207386, Exp. May 2019

Distribution pattern

Nationwide within the United States