Warner Chilcott US LLC recalls Enablex (darifenacin) Extended Release Tablet, 15 mg per tablet. Physician Sample 7 Tablets bottle, Rx only, Mfd by:
Recalled August 7, 2013 · FDA recall D-822-2013 · Warner Chilcott US
Hazard
Failed Impurities/Degradation Specifications: unspecified degradation product · FDA Class II
Units
188,600 bottles
Sold at
Nationwide
Description
Failed Impurities/Degradation Specifications: unspecified degradation product
Product
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
Manufacturer(s)
Warner Chilcott US LLC
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →