Exact FDA event identifier

Event 90949

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

Open FDA event record

Event summary

Timeline bucket: October 05, 2022
Product types: Drug
Classifications: Class II
Statuses: Completed
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

Quinapril and Hydrochlorothiazide Tablets, USP 20mg/12.5mg, 90 Tablets bottles Distributed by: Aurobindo Pharma USA, Inc. 279 Princeton-Hightstown Road East Windsor, NJ 08520, Made in India, NDC 65862-162-90

D-0021-2023

Recall number: D-0021-2023
Initiated: October 05, 2022
Classification: Class II
Status: Completed
Recalling firm: Aurobindo Pharma USA Inc.
Quantity: 9504 bottles

App-derived interpretation

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

N-Nitroso-quinapril impurity

Manufacturing or process control reason.manufacturing_process_control · v1.0.0

CGMP Deviations

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

CGMP Deviations: Detection of N-Nitroso-quinapril impurity above the acceptable daily intake limit.

Code information

Lots QE2021005-A and QE2021010-A, exp 01/2023

Distribution pattern

Nationwide