Exact FDA event identifier

Event 89045

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

Event summary

Timeline bucket: November 15, 2021
Product types: Drug
Classifications: Class III
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

Carvedilol Tablets, USP, 6.25 mg, 500 Tablets bottle, Rx Only, Distributed by: Aurobindo Pharma USA Inc., 279 Princeton-Hightstown Road, East Windsor, NJ, 08520, Made in India, NDC 65862-143-05

D-0263-2022

Recall number: D-0263-2022
Initiated: November 15, 2021
Classification: Class III
Status: Terminated
Recalling firm: Aurobindo Pharma USA Inc.
Quantity: 7296 containers

App-derived interpretation

Potency or specification failure reason.potency_specification_failure · v1.0.0

Failed Impurities/Degradation Specifications

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Failed Impurities/Degradation Specifications

Code information

Batch QG0619030-A, exp 11/2022

Distribution pattern

Nationwide in the US