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Class II · ModerateRecall completed

Accuretic (quinapril HCl/hydrochlorothiazide) Tablets

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

Does this affect you?
Check your lot numberLot FG5379; Exp. 08/2024
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 / forParke-Davis, Division of Pfizer Inc, NY, NY 10017
NDC0071-3112-23
Show the full FDA record
Full product labelAccuretic (quinapril HCl/hydrochlorothiazide) Tablets, 10 mg/12.5 mg*, 90 Tablets bottles, Rx Only, Distributed by: Parke-Davis, Division of Pfizer Inc, NY, NY 10017, Made in Germany, NDC 0071-3112-23.
Recalling firmPfizer Inc.
DistributionNationwide
Quantity53 bottles
Recall initiated2022-03-21
Report date2022-04-13
Recall completed2024-08-28
Recall numberD-0754-2022
ClassificationClass II
FDA statusTerminated
Origin on fileNew York NY 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.