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Class II · ModerateRecall completed

Quinapril Hydrochloride/Hydrochlorothiazide

Could cause temporary or reversible harm; serious harm is unlikely.

Does this affect you?
Check your lot numberLots QE2021005-A and QE2021010-A, exp 01/2023
Where it was soldNationwide
Find the lot number printed on your box or bottle. If it matches — and you take this medicine — call your pharmacist. Don't stop a prescribed medicine on your own.

What happened

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

What to do

  1. Check the lot number and expiry on your medicine against the recall above.
  2. Talk to your pharmacist or doctor before changing anything — don't stop on your own.
  3. Report any problems to FDA MedWatch (1-800-FDA-1088 or fda.gov/medwatch).

Who makes it

Made byMade in India foreign manufacturer
Brand nameQUINAPRIL HYDROCHLORIDE/HYDROCHLOROTHIAZIDE
Generic nameQUINAPRIL HYDROCHLORIDE/HYDROCHLOROTHIAZIDE
Active ingredient(s)HYDROCHLOROTHIAZIDE, QUINAPRIL HYDROCHLORIDE
Distributed by / forAurobindo Pharma USA, Inc. 279 Princeton-Hightstown Road East Windsor, NJ 08520
NDC65862-162-90
Show the full FDA record
Full product labelQuinapril 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
Recalling firmAurobindo Pharma USA Inc.
DistributionNationwide
Quantity9504 bottles
Recall initiated2022-10-05
Report date2022-11-02
Recall completed—
Recall numberD-0021-2023
ClassificationClass II
FDA statusCompleted
Origin on fileEast Windsor NJ United States

Related

Hydrochlorothiazide recallsQuinapril recallsRecent drug recallsCheck another medication

Source: U.S. FDA enforcement database (openFDA). Look this up on the official FDA recalls site ↗

This is public FDA recall information, not medical advice. A recall does not always mean your specific bottle is affected. Never stop a prescribed medicine without asking your pharmacist or doctor.