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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 66528

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

Open FDA event record

Event summary

Timeline bucket
October 09, 2013
Product types
Drug
Classifications
Class II
Statuses
Terminated
Recalling firm wording
Actavis Elizabeth LLC

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

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 Orally Disintegrating Tablets, USP 2 mg, 100 count bottles, Rx Only, MFG. BY ACTAVIS ELIZABETH LLC., Elizabeth, NJ, NDC 0228-4025-11

D-018-2014
Recall number
D-018-2014
Initiated
October 09, 2013
Classification
Class II
Status
Terminated
Recalling firm
Actavis Elizabeth LLC
Quantity
756 bottles

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Failed Tablet/Capsule Specifications; partial tablet erosion resulting in tablet weights below specification in some tablets

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Failed Tablet/Capsule Specifications; partial tablet erosion resulting in tablet weights below specification in some tablets

Code information

Lot # 59380831, Exp. May 2014

Distribution pattern

Nationwide