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U.S. Department of Health and Human Services

Enforcement Report - Week of August 7, 2013

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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
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