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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 91279

2 recalled-product records grouped only because every row carries this exact official event ID.

Open FDA event record

Event summary

Timeline bucket
December 07, 2022
Product types
Drug
Classifications
Class II
Statuses
Terminated
Recalling firm wording
Lupin Pharmaceuticals 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

2 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 2

Quinapril Tablets USP, 40 mg (90 pack), Rx Only, Manufactured for: Lupin Pharmaceuticals, Inc. Baltimore, Maryland 21202, by: Lupin Limited, Goa 403 722 India, NDC# 68180-554-09

D-0088-2023
Recall number
D-0088-2023
Initiated
December 07, 2022
Classification
Class II
Status
Terminated
Quantity
30,612 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

Lot #: G100533, G100534, Exp. 12/2022; G203071, Exp. 03/2024

Distribution pattern

Product was distributed by major distribution chains nationwide.

drug · product 2 of 2

Quinapril Tablets USP, 20 mg (90 pack), Rx Only, Manufactured for: Lupin Pharmaceuticals, Inc. Baltimore, Maryland 21202, by: Lupin Limited, Goa 403 722 India, NDC# 68180-558-09

D-0089-2023
Recall number
D-0089-2023
Initiated
December 07, 2022
Classification
Class II
Status
Terminated
Quantity
23,736

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

Lot #: G102929, Exp 04/2023

Distribution pattern

Product was distributed by major distribution chains nationwide.