Reported Nov 11, 2015 · Terminated

Fenoglide (fenofibrate) tablets, 120 mg Tablets, 90 Ct Bottle, Rx Only. Distributed by: Santarus, Inc. San Diego, CA…

Valeant Pharmaceuticals North America LLC

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: Valeant Pharmaceuticals North America LLC · 400 Somerset Corporate Blvd · Bridgewater, NJ · 08807-2867

Is this the product you have?

  • Fenoglide (fenofibrate) tablets, 120 mg Tablets, 90 Ct Bottle, Rx Only
  • Distributed bySantarus, Inc. San Diego, CA 92130
  • NDC68012-495-90
Lot codes and dates
  • Lot # 1300939
  • ExpiryMarch 2016
Amount recalled
3341 Bottles

Where it was sold

  • Nationwide

Why it was recalled

Failed Dissolution Specifications: Failed 24 month dissolution testing.

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 Mar 14, 2017 · Data as of Sep 19, 5:44 PM UTC

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