Product Detail

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

Recall Number D-822-2013

Classification Class II

Code Info Lot F1002 - Exp.12/13

Product Distributed Qty 188,600 bottles

Reason For Recall Failed Impurities/Degradation Specifications: unspecified degradation product

Event Detail

Event Id 65461

Product Type Drugs

Status Ongoing

Recalling Firm

Warner Chilcott US LLC
City Rockaway

State NJ
Country US

Voluntary / Mandated Voluntary: Firm Initiated

Recall Initiation Date 2013-05-17

Initial Firm Notification of Consignee or Public Letter

Distribution Pattern Nationwide