QUINAPRIL HCL AND HYDROCHLOROTHIAZIDE

Generic: QUINAPRIL HCL AND HYDROCHLOROTHIAZIDE, QUINAPRIL AND HYDROCHLOROTHIAZIDE

Lupin PharmaceuticalsManufacturer

ORALRoute

QUINAPRIL HYDROCHLORIDEActive Substance

2004-03-31Original Approval

QUINAPRIL HCL AND HYDROCHLOROTHIAZIDE is FDA application ANDA076374, sponsored by CHARTWELL RX. Any recalls listed below come from FDA drug enforcement reports, and reaction counts are the number of FAERS adverse event reports that mention the drug and that reaction; a report does not prove the drug caused it.

Recalls

Class II2013-09-17

Quinapril Tablets USP, 10 mg, 90 count bottle, Rx only, Manufactured for: Lupin Pharmaceuticals, Inc., Baltimore, MD 21

Failed Impurities/Degradation Specifications: During stability testing an unknown impurity was found

Class II2022-12-07

Quinapril Tablets USP, 20 mg (90 pack), Rx Only, Manufactured for: Lupin Pharmaceuticals, Inc. Baltimore, Maryland 21202

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

Class II2022-12-07

Quinapril Tablets USP, 40 mg (90 pack), Rx Only, Manufactured for: Lupin Pharmaceuticals, Inc. Baltimore, Maryland 21202

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

Class III2015-12-07

Quinapril Tablets USP 5 mg, 90 count bottles, Lupin Pharmaceuticals, Inc., Baltimore, MD --- NDC 68180-556-09

Failed Impurities/Degradation Specifications; Impurity A

Class II2013-09-17

Quinapril Tablets USP, 5 mg, 90 count bottle, Rx only, Manufactured for: Lupin Pharmaceuticals, Inc., Baltimore, MD 212

Failed Impurities/Degradation Specifications: During stability testing an unknown impurity was found

Class II2022-10-05

Quinapril and Hydrochlorothiazide Tablets, USP 20mg/12.5mg, 90 Tablets bottles Distributed by: Aurobindo Pharma USA, Inc

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

QUINAPRIL HCL AND HYDROCHLOROTHIAZIDE

Recalls

Top Reported Reactions