Quinapril Hydrochloride/hydrochlorothiazide Tablet, Film Coated
FDA Recall NDC 65862-162
FDA Enforcement Report: View Recall Date, Reasons, and Safety Status
Active & Historical Enforcement Reports
The FDA has identified 1 recorded enforcement report(s) associated with Quinapril Hydrochloride/hydrochlorothiazide (NDC 65862-162). A significant event, classified as Class II, was initiated on Oct 05, 2022 by Aurobindo Pharma Limited. The reported reason for this action was: "CGMP Deviations: Detection of N-Nitroso-quinapril impurity above the acceptable daily intake limit."
This specific recall has a current status of COMPLETED, indicating that the FDA considers the recall process finished or the product successfully recovered.
This specific recall has a current status of COMPLETED, indicating that the FDA considers the recall process finished or the product successfully recovered.
Reported Recall Events
Class II Completed
CGMP Deviations: Detection of N-Nitroso-quinapril impurity above the acceptable daily intake limit.
Oct 05, 2022
Nov 02, 2022
9504 bottles
Recall Profile & Regulatory Data
Event ID
90949
Classification
Class II
Enforcement Status
Completed
Recalling Firm
Aurobindo Pharma USA Inc.
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Nationwide
Product Description
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
Batch or Lot Expiration Information
Lot# Lots QE2021005-A and QE2021010-A, exp 01/2023
Affected Packages Involved in this Recall
65862-161-90Product
65862-162-30Product
65862-162-90Product
65862-163-90Product
About FDA Recall Enforcement Reports
FDA recall data documents classified recall actions associated with a product. Most recalls are limited to specific lots, batches, or package configurations rather than every unit of a drug.
If a recall is listed for an NDC, review the affected lot information and package details carefully. Patients and healthcare professionals should confirm whether a specific product in hand matches the lot or package information before assuming it is affected.
