Reported Jan 22, 2014 · Terminated

Quinapril Tablets USP, 5 mg, 90 count bottle, Rx only, Manufactured for: Lupin Pharmaceuticals, Inc., Baltimore, MD…

Lupin Pharmaceuticals Inc.

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

What you should do

Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.

Firm contact: Lupin Pharmaceuticals Inc. · 111 S Calvert St Fl 21st · Baltimore, MD · 21202-6174

Is this the product you have?

  • Quinapril Tablets USP, 5 mg, 90 count bottle, Rx only
  • Manufactured forLupin Pharmaceuticals, Inc., Baltimore
  • MD 21202 United States Manufactured by
    • Lupin Limited Goa 403 722 INDIA
    • NDC 68180-556-09
Lot codes and dates
    • Lots 3104879
    • 3104880
    • Exp. 10/13
    • 3110218
    • 3110219
    • 3110220 Exp. 12/13
Amount recalled
30,264 bottles

This recall covers 2 products

The agency filed one notice per product. You are reading one of them; the other one is below.

Where it was sold

  • Nationwide
  • PR

Why it was recalled

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

This product could cause temporary or reversible health problems — stop using it.

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Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA drug enforcement) notice

Notice updated May 11, 2016 · Data as of Sep 19, 7:55 PM UTC

RecallNow is not a government agency. Every fact on this page is published by the FDA, USDA or CPSC and links back to their notice.