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
Recall Number: D-822-2013
Firm: Warner Chilcott US LLC
Classification: Class II
Status: Terminated
Report Date: 20130807
Initiation Date: 20130517
Termination Date: 20151130
Reason for Recall
Failed Impurities/Degradation Specifications: unspecified degradation product
Product Description
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