Reported Aug 7, 2013 · Terminated

Enablex (darifenacin) Extended Release Tablet, 15 mg per tablet. Physician Sample 7 Tablets bottle, Rx only, Mfd by:…

Warner Chilcott US 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: Warner Chilcott US LLC · 100 Enterprise Dr · Rockaway, NJ · 07866-2116

Is this the product you have?

  • Enablex (darifenacin) Extended Release Tablet, 15 mg per tablet. Physician Sample 7 Tablets bottle, Rx only
  • Mfd byNovartis Pharma Stein AG, Stein, Switzerland, NDC 0078-9420-07
Lot codes and dates
  • Lot F1002 - Exp.12/13
Amount recalled
188,600 bottles

Where it was sold

  • Nationwide

Why it was recalled

Failed Impurities/Degradation Specifications: unspecified degradation product

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 Nov 30, 2015 · Data as of Sep 19, 5:01 PM UTC

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