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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 numberLots 3104879, 3104880, Exp. 10/13, 3110218, 3110219, 3110220 Exp. 12/13
Where it was soldNationwide and Puerto Rico
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

Failed Impurities/Degradation Specifications: During stability testing an unknown impurity was found to be above the specification limit at 36 month test interval

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 Limited Goa 403 722 INDIA foreign manufacturer
Brand nameQUINAPRIL
Generic nameQUINAPRIL
Active ingredient(s)QUINAPRIL HYDROCHLORIDE
Distributed by / forLupin Pharmaceuticals, Inc., Baltimore, MD 21202 United States
NDC68180-556-09
Show the full FDA record
Full product labelQuinapril Tablets USP, 5 mg, 90 count bottle, Rx only, Manufactured for: Lupin Pharmaceuticals, Inc., Baltimore, MD 21202 United States Manufactured by: Lupin Limited Goa 403 722 INDIA, NDC 68180-556-09
Recalling firmLupin Pharmaceuticals Inc.
DistributionNationwide and Puerto Rico
Quantity30,264 bottles
Recall initiated2013-09-17
Report date2014-01-22
Recall completed2016-05-11
Recall numberD-408-2014
ClassificationClass II
FDA statusTerminated
Origin on fileBaltimore MD United States

Related

Quinapril 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.