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Class II · ModerateRecall completed

quinapril HCl/hydrochlorothiazide tablets

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

Does this affect you?
Check your lot numberLots DN6931, ED3904 & ED3905; Exp. 03/2023
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: N-nitroso-quinapril and N-nitroso-hydrochlorothiazide 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 Germany foreign manufacturer
Distributed by / forGreenstone, LLC, Peapack, NJ, 07977
NDC59762-0220-1
Show the full FDA record
Full product labelquinapril HCl/hydrochlorothiazide tablets, 20 mg/12.5 mg*, 90 Tablets bottles, Rx Only, Distributed by: Greenstone, LLC, Peapack, NJ, 07977, Made in Germany, NDC 59762-0220-1
Recalling firmPfizer Inc.
DistributionNationwide
Quantity21108 bottles
Recall initiated2022-03-21
Report date2022-04-13
Recall completed2024-08-28
Recall numberD-0759-2022
ClassificationClass II
FDA statusTerminated
Origin on fileNew York NY United States

Related

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.