Reported Nov 27, 2013 · Terminated

Omeprazole Delayed-Release Capsules, USP, 20 mg, Rx Only, 1000 Capsules per bottle, Distributed by: Kremers Urban…

Kremers Urban 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: Kremers Urban Pharmaceuticals, Inc. · 1101 C Ave W · Seymour, IN · 47274-3342

Is this the product you have?

  • Omeprazole Delayed-Release Capsules, USP, 20 mg, Rx Only, 1000 Capsules per bottle
  • Distributed byKremers Urban Pharmaceuticals Inc. Princeton, NJ 08540, USA
  • NDC62175-118-43
Lot codes and dates
    • Lot Number 59627
    • Expiration Date 02/2014
Amount recalled
3867 bottles

Where it was sold

Why it was recalled

Failed Tablet/Capsule Specification: some capsules over time do not meet or are suspected to not meet the specification for acid resistance.

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 9, 2014 · Data as of Sep 19, 4:59 PM UTC

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