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U.S. Department of Health and Human Services

Enforcement Report - Week of July 31, 2013

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Product Detail

Product Description Diclofenac Sodium and Misoprostol Delayed-Release Tablets, 75mg/0.2mg, 60-count bottle, Rx only, Manufactured by Watson Laboratories, Inc., Corona, CA 92880, NDC 0591-0398-60
Recall Number D-817-2013
Classification Class II
Code Info Lot 635098A, Exp 10/14
Product Distributed Qty 392,400 tablets
Reason For Recall Failed Tablet/Capsule Specifications: Broken tablets

Event Detail

Event Id 65541
Product Type Drugs
Status Ongoing
Recalling Firm Watson Laboratories, Inc.-(Actavis) - Florida
City Davie
State FL
Country US
Voluntary / Mandated Voluntary: Firm Initiated
Recall Initiation Date 2013-03-22
Initial Firm Notification of Consignee or Public Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Distribution Pattern Nationwide