Product Safety Recalls

Product Recall Tracker

QUINAPRIL HYDROCHLORIDE Recall D-0089-2023

Description: 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

QUINAPRIL HYDROCHLORIDE Recall D-0089-2023 Information

StatusOngoing
Mandated?Voluntary: Firm initiated
Recall NumberD-0089-2023
Event ID91279
BrandQUINAPRIL
Generic NameQUINAPRIL
ManufacturerQUINAPRIL
Original Package?1
Active SubstanceQUINAPRIL HYDROCHLORIDE
Drug RouteORAL
DistributionProduct was distributed by major distribution chains nationwide.
Quantity23,736
Recall ReasonCGMP Deviations: Detection of N-Nitroso-quinapril impurity above the acceptable daily intake limit.
Drug ClassificationClass II
Drug Code Info20221228
Product NDC68180-554 68180-556 68180-557
Drug UPC0368180556091
Recall Initiation Date20221207
Report Date20221228
Classification Date20221223
AddressHarborplace Tower111 S Calvert St Fl 21st
Baltimore, MD 21202-6174
United States
Recalling FirmLupin Pharmaceuticals Inc.
Initial Notification Letter
Unique Ingredient Identifier33067B3N2M
Drug Application NumberANDA077690
Structured Product Labeling (SPL ID)a05f8d04-435a-4157-9b50-febe11b1ab1a
Structured Product Labeling (SPL Set ID)8ded0773-3aec-4e89-9836-d22a5a84abf0
Similar To

© 2022 Recall.Report / Contact / Privacy Policy

This site's data is aggregated programmatically and provided "as is" without any representations or warranties, express or implied.
Recall.report is not affiliated with the Consumer Product Safety Commision, FDA, or US government in any way.