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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