Reported Nov 2, 2022 · Completed

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

Aurobindo Pharma USA Inc.

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

What you should do

Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.

Firm contact: Aurobindo Pharma USA Inc. · 279 Princeton Hightstown Rd · East Windsor, NJ · 08520-1401

Is this the product you have?

    • Quinapril and Hydrochlorothiazide Tablets
    • USP 20mg/12.5mg
    • 90
  • Tablets bottles Distributed byAurobindo Pharma USA, Inc. 279 Princeton-Hightstown Road East Windsor, NJ 08520, Made in India, NDC 65862-162-90
Lot codes and dates
    • Lots QE2021005-A and QE2021010-A
    • exp 01/2023
Amount recalled
9504 bottles

Where it was sold

  • Nationwide

Why it was recalled

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

This product could cause temporary or reversible health problems — stop using it.

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Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA drug enforcement) notice

Data as of Sep 19, 6:39 PM UTC

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