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