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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 80964

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

Open FDA event record

Event summary

Timeline bucket
September 10, 2018
Product types
Drug
Classifications
Class II
Statuses
Terminated
Recalling firm wording
Takeda Development Center Americas, 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

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

Actoplus met XR (pioglitazone and metformin HCl, extended-release) tablets, 15 mg/1000 mg, Rx Only, 30 tablet bottle, Distributed by: Takeda Pharmaceuticals America, Inc, Deerfield, IL 60015. NDC: 64764-510-30

D-0026-2019
Recall number
D-0026-2019
Initiated
September 10, 2018
Classification
Class II
Status
Terminated
Quantity
7,248 bottles

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Defective Delivery System: tablets may be missing, in whole or in part, the laser drilled holes on the metformin core of the Actoplus met XR tablets.

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Defective Delivery System: tablets may be missing, in whole or in part, the laser drilled holes on the metformin core of the Actoplus met XR tablets.

Code information

Lot, expiry: A26004, exp Apr 2020; A26443 and A26444, exp Sep 2020

Distribution pattern

AR, LA, MS, NC, NJ, OH, PA, SC and Puerto Rico