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U.S. Department of Health and Human Services

Enforcement Report - Week of February 19, 2014

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Product Detail

Product Description Diclofenac Sodium and Misoprostol Delayed-Release Tablets, 75 mg/0.2 mg, 60-count bottle, Rx only, Manufactured by: Watson Laboratories, Inc., Corona, CA 92880, NDC 0591-0398-60, UPC 3 05910 39860 6.
Recall Number D-1082-2014
Classification Class II
Code Info Lot# 605957A, Exp 09/14
Product Distributed Qty 5987 bottles
Reason For Recall Failed Tablet/Capsule Specifications: Split tablets were found in the 12-month stability samples.

Event Detail

Event Id 67259
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 2013-12-20
Initial Firm Notification of Consignee or Public E-Mail
Distribution Pattern Nationwide