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Class II · ModerateRecall completed

Quinapril

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

Does this affect you?
Check your lot numberLot #: G102929, Exp 04/2023
Where it was soldProduct was distributed by major distribution chains nationwide.
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 byLupin Pharmaceuticals, Inc.
Brand nameQUINAPRIL
Generic nameQUINAPRIL
Active ingredient(s)QUINAPRIL HYDROCHLORIDE
Distributed by / forLupin Pharmaceuticals, Inc. Baltimore, Maryland 21202, by: Lupin Limited, Goa 403 722 India
NDC68180-558-09
Show the full FDA record
Full product labelQuinapril Tablets USP, 20 mg (90 pack), Rx Only, Manufactured for: Lupin Pharmaceuticals, Inc. Baltimore, Maryland 21202, by: Lupin Limited, Goa 403 722 India, NDC# 68180-558-09
Recalling firmLupin Pharmaceuticals Inc.
DistributionProduct was distributed by major distribution chains nationwide.
Quantity23,736
Recall initiated2022-12-07
Report date2022-12-28
Recall completed2024-08-01
Recall numberD-0089-2023
ClassificationClass II
FDA statusTerminated
Origin on fileBaltimore MD United States

Related

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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.