FDAFDA · Food and drugs·Recall number D-822-2013
Enablex (darifenacin) Extended Release Tablet, 15 mg per tablet. Physician Sample 7 Tablets bottle, Rx only, Mfd by: Novartis Pharma Stein AG, Stein, Switzerland, NDC 0078-9420-07
Published August 7, 2013 · Recall initiated: May 17, 2013
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Failed Impurities/Degradation Specifications: unspecified degradation product
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Warner Chilcott US LLC
- Distributor
- Nationwide
- Lot
- Lot F1002 - Exp.12/13
- Risk classification
- Class II
- Area (FDA)
- drug
- Country
- United States
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