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U.S. Department of Health and Human Services

Enforcement Report - Week of January 23, 2013

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Product Detail

Product Description Divalproex Sodium Delayed-Release Tablets, USP, 500 mg Valproic Acid Activity, 100-count tablets per bottle, Rx only, Manufactured by Upsher-Smith Laboratories, Inc., Minneapolis, MN 55447, NDC 0245-0182-11.
Recall Number D-127-2013
Classification Class III
Code Info Lot #: 310162, Exp 09/14
Product Distributed Qty 11,316 bottles
Reason For Recall Labeling: Label Error On Declared Strength; Some bottles of product were missing the color-coded strength on the primary display panel of the label.

Event Detail

Event Id 64085
Product Type Drugs
Status Ongoing
Recalling Firm Upsher Smith Laboratories, Inc.
City Maple Grove
State MN
Country US
Voluntary / Mandated Voluntary: Firm Initiated
Recall Initiation Date 2012-12-10
Initial Firm Notification of Consignee or Public Telephone
Distribution Pattern Nationwide and Puerto Rico