Exact FDA event identifier

Event 89323

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

Event summary

Timeline bucket: December 29, 2021
Product types: Drug
Classifications: Class II
Statuses: Terminated
Recalling firm wording: Aurobindo Pharma USA 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

Pioglitazone Tablets USP, 45 mg, 500 count bottles, Distributed by: Aurobindo Pharma USA, Inc., East Windsor, NJ -- NDC 57237-221-05

D-0450-2022

Recall number: D-0450-2022
Initiated: December 29, 2021
Classification: Class II
Status: Terminated
Recalling firm: Aurobindo Pharma USA Inc.
Quantity: 792 bottles

App-derived interpretation

Potency or specification failure reason.potency_specification_failure · v1.0.0

Superpotent

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Superpotent and Failed Tablet/Capsule Specifications

Code information

Batch # PF4520028B & PF4520028A, Exp. Date 11/2022

Distribution pattern

Nationwide in the US