Exact FDA event identifier

Event 68900

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

Event summary

Timeline bucket: July 25, 2014
Product types: Drug
Classifications: Class II
Statuses: Terminated
Recalling firm wording: Sandoz Incorporated

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

Alprazolam Tablets, USP, 0.25mg, Rx only, 1000 tablets, Sandoz Inc., Princeton, NJ --- NDC 0781-1061-10

D-1509-2014

Recall number: D-1509-2014
Initiated: July 25, 2014
Classification: Class II
Status: Terminated
Recalling firm: Sandoz Incorporated
Quantity: 1,332 bottles

App-derived interpretation

Foreign material or chemical contamination reason.foreign_material_chemical_contamination · v1.0.0

Foreign Substance

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Presence of Foreign Substance; tablets may contain stainless steel metal particulates

Code information

Lot EJ9591

Distribution pattern

Nationwide