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U.S. Department of Health and Human Services

Enforcement Report - Week of August 7, 2013

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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
Distribution Pattern Nationwide

Product Detail

Product Description Code Info Classification Reason for Recall Product Quantity Recall Number
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 Lot F1002 - Exp.12/13 Class II Failed Impurities/Degradation Specifications: unspecified degradation product 188,600 bottles D-822-2013